Part 4 Medical Devices for Neurosurgical Treatment

Transcription

1 Crown Agents Reference: CA/107403/0004/001 (REVISED) Date: 2 February 2017 (RE-ISSUE DATE) Dear Sirs BID CLOSING DATE 9 February 2017 at 13:00hrs UK time (GMT) AT CROWN AGENTS SUTTON, UK INVITATION TO BID ( ITB ) FOR PROGRAMME XIX: MEDICAL PRODUCTS FOR HEALTHCARE INSTITUTIONS FOR TREATMENT OF PATIENTS WITH CARDIOVASCULAR AND CEREBROVASCULAR DISEASES Part 4 Medical Devices for Neurosurgical Treatment Crown Agents Limited ( Crown Agents ), acting as a specialised organisation within the meaning of the Law of Ukraine On Performance of State Procurement, invite you to submit a bid for the supply of Goods as specified in the attached Appendices. This ITB is issued for the purpose of execution of the Agreement number 1/57 dated 27 October 2016 between Crown Agents and the Ministry of Health of Ukraine on the procurement of medicines and medical products in accordance with the Resolution of the Cabinet of Ministers of Ukraine dated 23 August 2016 N 557 under the Directions of State Funds Allocations for 2016 under the Budget Program On Support of Healthcare Measures under separate state programs and complex measures of the programme nature. This ITB comprises of the following documents: Instructions for bidding Specifications and Technical Quality Criteria Technical Offer and Statement of Compliance Bid Form Manufacturer s Authorisation Form if the bidder is not the manufacturer) Major relevant supplies in past three (3) years Business Partner Questionnaire Draft Form of Contract Appendix A Appendix B Appendix C Appendix D Appendix E Appendix F Appendix G Appendix H Instructions for Bidding The bid must include each of the documents identified below, fully completed by the bidder together with any supporting literature required by the relevant document. Technical Offer and Statement of Compliance (Appendix C) Bid Form (Appendix D) Manufacturer s Authorisation Form (if applicable) (Appendix E) Major relevant supplies in past three (3) years (Appendix F) Crown Agents Business Partner Questionnaire (see below) (Appendix G) Page 1

2 Crown Agents reserve the right (at its absolute discretion) to request further documentary evidence of registration as it considers necessary. The draft form of Contract attached at Appendix H identifies the documents that shall be incorporated into any resulting Contract. It is the bidder s responsibility to ensure that its bid complies with all the requirements stipulated in this ITB and in any resulting award of Contract (including but not limited to) the General and Special Conditions of Contract. Business Partner Questionnaire (BPQ) If you have not completed and submitted a Business Partner Questionnaire to Crown Agents within the past 24 months you are required to complete and submit one as attached at Appendix G. This is required to establish the bidder s capability to perform any subsequent Contract. Complete all sections and attach the documents requested. Failure to provide such information may result in your offer not being considered. Electronic Submissions Your bid (appendices C, D, E, F and G with any covering letter (remarks) should be submitted electronically in PDF format to scstenderbox@crownagents.co.uk by 9 February The electronic message header must contain the reference CA/107403/0004/001, PROGRAMME XIX Part 4 and Not to be opened before the bid closing date 9 February 2017 at 13:00hrs UK time (GMT). All documents attached to the electronic message must be clearly titled as Covering Letter, Appendix C, Appendix D, Appendix E etc. The maximum size of each electronic submission is 16MB. It the bid exceeds 16MB it may be submitted in parts, and each part submission must be correctly referenced. Crown Agents will request hard copies of supporting documents, as detailed in Instructions to Bidders (Appendix A), from the first ranked bidder of each item/lot. The first ranked bidder must submit these documents within 5 working days of request for their bid to be considered further. Hard copy documents should be sent to: MOH Ukraine Project (Attn: Aysel Abasova) Supply Chain Services Crown Agents St Nicholas House St Nicholas Road Sutton, Surrey SM1 1EL, UK Bids must comply with the following conditions: Bidders should read all instructions at Appendix A carefully before completing the bid documentation. Failure to comply with any instructions concerning completion and submission of the bid may render (at Crown Agents absolute discretion) the bid non-compliant and the bid may be excluded from this competitive bidding exercise. Bids are sought on a competitive basis and all prices are subjected to detailed scrutiny and may be subject to negotiation. The bid as well as all correspondence and documents relating to the bid, between the bidder and Crown Agents, shall be in the English language. Page 2

3 ITB acknowledgement and intention to submit a bid. Upon receipt of this ITB, bidders are requested to send an acknowledgment by to Aysel Abasova ( aysel.abasova@crownagents.co.uk) confirming receipt. Further, you are requested to notify Aysel Abasova in writing of your intention to submit a bid no later than 7 February If you are declining to submit a bid we request notification with the reason(s) why you are declining this opportunity. Yours faithfully Christine Jackson Team Leader / Principal Procurement Consultant Direct Tel: +44 (0) christine.jackson@crownagents.co.uk Page 3

4 INSTRUCTIONS FOR BIDDING APPENDIX A 1. Funding: Funds in respect of any Contract awarded as a result of this ITB will be held in an account with Crown Agents Bank. (Crown Agents Bank is a UK bank regulated by UK Banking Laws.) In preparing the bid the bidder should take into account the fact that funds to meet the costs of the contract will be held in United States Dollars (USD) by a U.K. bank. 2. Variant Bids: Variant bids are not acceptable and only one bid may be submitted by each bidder. 3. Currency: Bids must be presented in USD only. Any resulting Contract will be placed in USD and payments will be made in USD. Bids made in any other currency will be rejected. 4. Period of validity: 4.1. Bidders shall be bound by their bids for a period of 90 days from the deadline for the submission of the bid In exceptional circumstance and prior to the expiry of the original bid validity period, Crown Agents may ask bidders, in writing, for an extension of this period Bidders that agree to do such an extension will not be permitted to modify their bids. If they refuse, their participation in this bidding process will be terminated The successful bidder will be bound by its bid for a further period of 60 days following the notification, by Crown Agents, that it has been selected. 5. Clarification of bidding documents: 5.1. Any questions regarding this ITB should be sent to Aysel Abasova (aysel.abasova@crownagents.co.uk), in writing no later than 5 working days prior to the bid closing date (20 January 2017) 5.2. Where Crown Agents identifies new or additional information to be provided, it will ensure that such new or additional information is notified to all registered bidders as soon as reasonably practicable. Crown Agents may, at its sole and absolute discretion extend the deadline for submission of bids to provide bidders with sufficient time for any clarification response to be taken into account in their bid. 6. Amendment of bidding documents: 6.1. At any time prior to the deadline for submission of bids, Crown Agents, for any reason, whether at its own initiative or in response to a clarification requested by a prospective bidder, may (at its absolute discretion) modify the bidding documents in any way All bidders will be notified of the amendment in writing, and the amendment will be binding on them In order to allow bidders reasonable time in which to take the amendment into account in preparing their bids, Crown Agents (at its discretion), may extend the deadline for the submission of bids. 7. Compensation for Delay: The bidder s attention is drawn to Clause 19 of the General Contract Conditions. 8. Warranties: The bidder s attention is drawn to the provisions of Clause 7 of the General Contract Conditions. Page 4

5 9. Request for Third Party Payment: If the bidder will require payment to be made to a third party, any such request for payment to a third party must be clearly stated in the bid together with the reasons for the request. The bidder s attention is drawn to the provisions of Clauses 24.6 of the General Contract Conditions. 10. Delivery: The delivery period quoted should be the period between the date of receipt of an award of Contract and the date of completion of the Contract and the receipt by Crown Agents of all documentation required under the Contract. Time is of the essence and it is vital therefore that you provide their best and most accurate delivery and completion times. 11. Prices: The bidder will be deemed to have satisfied themselves, before submitting their bid as to (its)(their) correctness and completeness, to have taken account of all that is required for the full and proper performance of the Contract and to have included all costs associated with taking title of the goods in their rates and prices You should offer prices to Crown Agents on an item by item DAP to the named State Owned Enterprise ( SOE ) Warehouse, Kyiv. Your price should include all costs associated with having title of the goods prior to delivery DAP State Owned Enterprise ( SOE ) Warehouse, Kyiv The prices as stated in the Contract shall be fixed and not subject to any increases. 12. Expiry Dates: All bids submitted must detail the maximum shelf life available against all Goods offered and the Shelf Life remaining for all Goods to be supplied must match that stated in your bid. If there are any changes to the shelf life for whatever reason, this must be agreed in writing with Crown Agents prior to despatch. 13. Evaluation: The evaluation process will be conducted to ensure the most competitively priced technically compliant bid as follows: Stage One Preliminary Evaluation: Bid responses will be subject to a preliminary evaluation to ensure they are fully compliant with the bid submission requirements as detailed in the Cover Letter and Instructions to Bidders of this ITB. Crown Agents may (at its absolute discretion) reject any bid response which it considers is non-compliant with the submission requirements. Bid responses will be checked on a Pass/Fail basis that the bidder accepts the General Contract Conditions and Special Conditions and such other provisions as detailed in the ITB, as evidenced in the Bid form at Appendix D Stage Two Technical Compliance Evaluation: Those bid responses that have not been rejected at preliminary evaluation will be subject to technical evaluation for compliance with the Specification and Technical Quality Criteria (Appendix B) and Technical Offer and Statement of Compliance (Appendix C) and bids will be marked in accordance with the scoring detailed below. a) Full technical compliance with Appendix B will be evaluated on a Pass/Fail basis. b) Compliance with packing and labelling will be on a Pass/Fail basis c) Compliance with registration and quality requirements for Ukraine will be on a Pass/Fail basis. Stage Three Financial Evaluation: The price to be evaluated will be the total bid price item by item / lot by lot per full quantity DAP SOE Warehouse, Kyiv as stated in the Form of Bid in Appendix D ( the Total Bid Price ). Bidders will not be permitted to correct or withdraw material deviations or reservations once bids have been opened, the exception being arithmetical errors identified by Crown Agents during evaluation and following clarification, such arithmetical errors which must be adjusted at line item Page 5

6 level based on the offered unit price. The Total Bid Price will be amended accordingly for the purposes of the evaluation. 14. Clarification of bids: During evaluation of the bids, Crown Agents may, at its sole and absolute discretion, ask the bidder provide additional information supplementing or clarifying any of the information provided in response to the requests set out in this ITB. The request for clarification and the response shall be in writing No bidder shall contact Crown Agents on any matter relating to its bid, from the time of issue of the ITB to the time the contract is awarded, unless instructed to do so by Crown Agents and/or or reasons as stipulated in the ITB. If the bidder wishes to bring additional information to the notice of Crown Agents, it should do so accordance with the Clarification of Bidding Documents clause of these Instructions to Bidder Without prejudice to any other remedies (whether civil or criminal), any effort by a bidder to influence Crown Agents in its decisions on bid evaluation, bid comparison, or contract award will result in the rejection of the bid. 15. Confidentiality: Subject to the paragraph below, the contents of this ITB are being made available by Crown Agents on condition that the bidder: treats the information in the ITB and any related documents ( Information ) as confidential, save in so far as they are already in the public domain; does not disclose, copy, reproduce, distribute or pass any of the Information to any other person at any time or allow any of these things to happen, except where, and to the extent that, the Information has been publicised; does not use any of the Information for any purpose other than for the purposes of submitting (or deciding whether to submit) a bid; and does not undertake any publicity activity within any section of the media Bidders may disclose, distribute or pass any of the Information to the bidder s advisers, sub-contractors or to another person provided that: the disclosure is for the sole purpose of enabling a bid to be submitted and the person receiving the Information undertakes in writing to keep the Information confidential on the same terms as if that person were the bidder; or the bidder obtains the prior written consent of Crown Agents in relation to such disclosure, distribution or passing of Information; or the disclosure is made for the sole purpose of obtaining legal advice from external lawyers in relation to this bid exercise or to any contract arising from it; or the bidder is legally required to make such a disclosure In this paragraph, the definition of person includes but is not limited to any person, firm, body or association, corporate or incorporate By participating in this competitive exercise, the bidder understands and agrees and shall obtain agreement from all sub-contractors who participate in their bid that Crown Agents is permitted to disclose all information submitted to them as part of the bid to their client, Ministry of Health, Ukraine. The Ministry will have use of this information. 16. Contract Award Prior to the expiration of the period of bid validity, Crown Agents shall notify each first ranked bidder, for each item / multiple items / each lot / multiple lots, in writing, that its Bid has been accepted as the first ranked for that item / lot. Within five working days of this written notification the bidder must submit the following documents in hard copy to: MOH Ukraine Project (Attn: Aysel Abasova) Page 6

7 Supply Chain Services Crown Agents St Nicholas House St Nicholas Road Sutton, Surrey SM1 1EL, UK The documents to be submitted: A copy of Ukraine registration certificate of medicine / medical device; and / or Declaration of conformity of the medical device or documentary evidence regarding permission for exemption from registration If the expiry of the Ukraine registration of medicine / medical device is less than 90 (ninety) days - copy of the letter confirming the application for re-registration. If the medicine / medical device is not registered in Ukraine and has no declaration of conformity or documentary evidence regarding permission for exemption from registration, a letter of guarantee is required. This letter shall confirm the supplier s obligation to provide all the necessary documents (in accordance to Ukrainian legislation) within ten working days after signing the contract to make fast track registration and successfully complete that registration prior to delivery. If the medicine / medical device is already in the process of registration - the letter of guarantee should detail the information regarding the situation and progress of the registration process. Evidence of local registration and full copy of manufacturing licence (where the bidder is the manufacturer). Evidence of compliance with the requirements of the National Regulatory body for both medical devices and medicines in country of domicile. If the bidder is not the manufacturer; evidence of supplier/distributor registration in accordance with the legislation in country of domicile. A copy of operation guidance (manual) or drug label for medical products and any other technical documents required. A copy of the bidders registered annual accounts (audited if available) for the years 2014 and In addition we will request a copy of bid appendices C and D in an editable format (word or excel) to be submitted electronically 17. Signing of Contract: When Crown Agents notifies the successful bidder that its bid has been accepted, Crown Agents shall endeavour to send the bidder the Contract in the format provided at Appendix H incorporating all agreements between the parties As soon as practically possible, but no more than ten (10) working days following receipt of the Contract, the successful bidder shall sign and date the Contract and return it to Crown Agents at: MOH Ukraine Project (Attn: Aysel Absaova) Supply Chain Services Crown Agents St Nicholas House St Nicholas Road Sutton, Surrey SM1 1EL, UK 18. Disclaimers: Page 7

8 18.1. The bidding process is governed by and construed in accordance with the laws of England All material issued in connection with this ITB shall remain the property of Crown Agents and shall be used only for the purpose of this bid exercise Crown Agents shall not be committed to any course of action as a result of: issuing an ITB; communicating with a bidder or a bidder s representatives or agents in respect of this procurement; or any other communication between Crown Agents and any other party Bidders shall accept and acknowledge that by issuing this ITB Crown Agents shall not be bound to accept any bid and reserves the right not to award the Contract for some or all of the Goods for which bids are invited Participation in this process shall be treated by Crown Agents as acceptance by the bidder of all the terms and conditions contained in this ITB. This relates to the conduct of this bid exercise including any subsequent award of contract The ITB is issued on the basis that nothing contained in it shall constitute an inducement or incentive nor shall have in any other way persuaded a bidder to submit a bid or enter into the Contract or any other contractual agreement Bidders are solely responsible for the costs and expenses incurred in connection with the preparation and submission of their bid and all other stages of the selection and evaluation process. Under no circumstances will Crown Agents or any of their advisers, be liable for any costs or expenses borne by bidder, sub-contractors, suppliers or advisers in this competitive bid exercise. 19. Collusive Behaviour: A bidder must not (and shall ensure that its directors, employees, subcontractors, consortium members, advisers or companies within its group do not): fix or adjust any element of the bid by agreement or arrangement with any other person; or communicate with any person other than Crown Agents the value, price or rates set out in the bid or information which would enable the precise or approximate value, price or rates to be calculated by any other person; or enter into any agreement or arrangement with any other person that such other person shall refrain from submitting a bid; or share, permit or disclose to another person, access to any information relating to the bid (or another bid to which it is party) with any other person; or enter into any agreement or arrangement with any other person as to the amount of any bid submitted; or offer or agree to pay or give or does pay or give any sum or sums of money, inducement or valuable consideration directly or indirectly to any other person for doing or having done or causing or having caused to be done, in relation to any other bid or proposed bid, any act or omission except where such prohibited acts are undertaken with persons who are also participants in the bidder s bid, such as subcontractors, consortium members, advisers or companies within its group, or where disclosure to such person is made in confidence in order to obtain bids necessary for the preparation of the bid or obtain any necessary security If a bidder breaches these Collusive Behaviour requirements, Crown Agents will (without prejudice to any other criminal or civil remedies available to it) disqualify it from further participation in the competitive bid exercise. Page 8

9 19.3. Crown Agents will require the bidder to put in place any procedures or undertake any such action(s) that Crown Agents in its sole and absolute discretion considers necessary to prevent or curtail any collusive behaviour In this Collusive Behaviour section the word person includes any person, body or association, corporate or incorporate and the phrase any agreement or arrangement includes any transaction, formal or informal whether legally binding or not. Page 9

10 Specifications and Technical Quality Criteria APPENDIX B Item No. International nonproprietary name (INN) Unit Quantity Part 4 Medical Devices for Neurosurgical Treatment Medical devices for endovascular embolization of cerebral aneurysm with detachable microcoils Unit 797 including one microcoil Medical devices for endovascular embolization of cerebral aneurysm with detachable microcoils Unit 208 including one guiding catheter Medical devices for endovascular embolization of cerebral aneurysm with detachable microcoils Unit 242 including one microcatheter Medical devices for endovascular embolization of Unit cerebral aneurysm with detachable microcoils including one micro guidewire Medical devices for carotid artery stenting including Unit one carotid stent system Medical devices for carotid artery stenting including Unit one filter-basket for embolic protection Medical devices for carotid artery stenting including Unit one introducer sheath for carotid artery stenting Medical devices for carotid artery stenting including Unit one predilatation balloon Medical devices for carotid artery stenting including Unit one postdilatation balloon Balloon catheter for treatment of carotid-cavernous Unit fistula including one guiding catheter 109 Balloon catheter for treatment of carotid-cavernous Unit fistula including one detachable balloon guide 20 microcatheter Balloon catheter for treatment of carotid-cavernous Unit fistula including one detachable balloon Intracranial stents for the treatment of wide-necked Unit cerebral aneurysms Balloon catheters for wide-necked cerebral Unit aneurysms Medical devices for diagnostic cerebral angiography Unit including one puncture needle 2, Medical devices for diagnostic cerebral angiography Unit including one introducer 2, Medical devices for diagnostic cerebral angiography Unit including one guidewire 2, Medical devices for diagnostic cerebral angiography Unit including one catheter 2, Cerebral aneurysm clips Unit Medical devices to stop bleeding including one soluble hemostatic surgical dressing (size 7.5 х 5 cm) Medical devices to stop bleeding including one soluble hemostatic surgical dressing (size 20 х 10 cm) Medical devices for embolization of brain arteriovenous malformations including one implant for embolization of vessels Unit Unit Unit 1, Page 10

11 Item No. International nonproprietary name (INN) Unit Quantity Medical devices for embolization of brain Unit arteriovenous malformations including one delivery 53 micro catheter Medical devices for embolization of brain Unit arteriovenous malformations including one 45 hydrophilic guide wire Surgical local hemostatic agents for neurosurgery Unit (hemostatic fiber made of soluble oxidized 860 regenerated cellulose, size 5 х 7.5 cm) Surgical local hemostatic agents for neurosurgery Unit (hemostatic cotton wool made of soluble oxidized regenerated cellulose, size 2.5 х 5.1 cm) Surgical local hemostatic agents for neurosurgery Unit (SURGIFLO Hemostatic Matrix Kit) Elongated guiding catheter for distal endovascular Unit access 15 Technical/quality criteria: 1. Medical devices should be registered in Ukraine and/or authorised for use and/or commissioning (application) in accordance with the law. This requirement should be confirmed by: a) certified copy of the Declaration or copy of documents that confirm authorization of use and/or commissioning (application) of the medical device as the result of the fidelity certification in accordance with the technical guidelines, or b) certified copy of the Certificate of Medical Device Registration, that certifies availability of the medical device in the State Registry of Medical Technologies and Devices. Pursuant to the requirements of the Cabinet of Ministers of Ukraine Decree as of 02 October 2013 No. 753 On Approval of Technical Guidelines for Medical Devices, if the bidder offers a medical device of which the Certificate expires before 01 July 2017, the item shall be imported into Ukraine (produced therein) before the expiry of the state Registration Certificate for this item. To confirm the statements of the competitive bid an attested copy of customs declaration or a document confirming the manufacture date of the bid item shall be submitted. 2. To confirm medical and technical (technical) specification, the bidder shall confirm the appropriateness of the bid item with a copy of the application guidelines (user manual) for use (application) of the medical devices, technical documents, etc. 3. Shelf life of goods, as at the moment of delivery, shall be not less than seventy five (75) % of the total shelf life. Page 11

12 STATEMENT OF COMPLIANCE and TECHNICAL OFFER APPENDIX C STATEMENT OF COMPLIANCE Item No Product description Medical devices for endovascular embolization of cerebral aneurysm with detachable microcoils including one microcoil must have the following properties System of microcoils detachment Product s material Resistance to stretching The mechanism which ensures controlled and reliable detachment The products shall be produced of platinum alloy or equivalent Microcoil shall be resistant to stretching to avoid stretching in the course of installing or reinstalling of microcoils before its detachment Spatial configuration Availability of 2- dimensional and 3- dimensional configurations of the product Configurations diameter Microcoils length Degree of softness Availability of whole range of configurations diameters ranging from 2 mm to 20 mm Availability of whole range of lengths ranging from 2 cm to 40 cm Opportunity to choose the coils degree of softness. Medical devices for endovascular embolization of cerebral aneurysm with detachable microcoils including one guiding catheter must have the following properties Support Guiding catheter shall ensure active support. Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 12

13 Item No External diameter Configurations Tip structure Length Technology Coating Product description The external diameter of the catheter shall amount to 5, 6, 7, 8 F. There shall be various configurations of the catheter tip available Tip of the guiding catheter shall be soft, which reduces the risk of blood vessels damage Length of the catheter shall amount to 90 and 100 cm. Guiding catheters shall have metal braiding. Availability of hydrophilic coating characterized by antithrombogenic properties. Medical devices for endovascular embolization of cerebral aneurysm with detachable microcoils including one microcatheter must have the following properties Tip shape Availability of markers Internal diameter Internal coating Microcatheter shall offer the tip shapes as follows: straight, curvature with the angle of 45, curvature with the angle of 90, curvature J Availability of not less than 2 radiopaque distal markers at the tip for better visualisation and control over the coil s departure from the catheter. Internal diameter of the catheter shall be compatible with microguidewires of inches and inches. Internal lumen of the microcatheter shall have a coating, which facilitates Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 13

14 Item No Total length Product description manipulations with the guidewire and with the microcoils inside the microcatheter. Total length of the catheter shall amount to not less than 150 cm. Medical devices for endovascular embolization of cerebral aneurysm with detachable microcoils including one micro guidewire must have the following properties: Hydrophilic coating Atraumatic Rod structure Distal segment Guidewire core External diameter of the distal segment Microguidewire shall have a hydrophilic coating Microguidewire shall be atraumatic Microguidewire tip shall be characterized by a structure, providing its repeated shaping and reshaping Distal segment of the microguidewire shall be radiopaque Microguidewire core shall ensure controlled rotary motion and distal support There shall be two diameters of the guidewire available: inches and inches Medical devices for carotid artery stenting including one carotid stent system must have the following properties Stent material Stent shall be made of biomedical alloy. Stent system delivery Delivery system type - Monorail or equivalent. Stent design - Stent design shall ensure adaptation to different shapes of vessels. - Stent shall be self expanding. Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 14

15 Item No Radio-opacity Compatibility of the stentsystem with the guidewire Compatibility of the stentsystem with the guidewire catheter Range of stent diameters Shaft length Range of stent lengths Product description Stent shall have shall have high radio-opacity Stent system shall be compatible with guidewire of inches Stent system shall be compatible with guidewire catheter 8 F and introducer 6 F. From 6 to 9 mm. Not less than 130 cm. From 30 to 40 mm. Medical devices for carotid artery stenting including one filter-basket for embolic protection must have the following properties: Component parts Radio-opacity Delivery system configuration System properties Dimensions of the filterbasket for embolic protection The system shall be comprised of the following components: antiembolic filter (filterbasket for embolic protection), device for its introduction and device for its removal. Antiembolic filter shall have radiopaque markers Filter delivery system design shall ensure atraumatic conducting of the filter through the area of stenotic lesions of carotid artery. The device shall perfectly adhere to the walls of blood vessels regardless of the angle of the guidewire location Filter-baskets for embolic protection shall be characterized by dimensions adapted to the artery diameter 4, 5 and 6 mm. Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 15

16 Item No Compatibility with the guidewire Item length Filter properties Product description The system components shall be compatible with guidewire inches. Over 150 cm. The filter design shall ensure holdback of embolic fragments and preserve the blood flow along the carotid artery. Medical devices for carotid artery stenting including one introducer sheath for carotid artery stenting must have the following properties: Dimension of introducer Components of introducer Material of introducer 8 F, length shall amount to not less than 11 cm Introducer with hemostatic valve and a lateral port with a 3-way tap, vascular dilator with a port for Luer system syringe, guidewire. Radiopaque polyurethane with special reinforced structure or equivalent, which prevents the bending of introducer, regardless of the patient s position. Medical devices for carotid artery stenting including one predilatation balloon must have the following properties: Balloon length Diameter Balloon catheter shall be characterized by length ranging from 20 mm to 30 mm. The smallest diameter of balloon shall not exceed 2.0 mm. Spectrum of balloons diameters: from 2.0 mm to 4.0 mm with the spacing of 1 mm. Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Delivery system Delivery system type - Monorail or equivalent. Page 16

17 Item No. Compatibility with guidewire Compatibility with the guidewire catheter Markers of balloon Product description Balloon catheter shall be compatible with guidewire of inches. Balloon catheter shall be compatible with guidewire catheter 7F Availability of radiopaque markers Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Nominal pressure Coating Nominal pressure of balloon catheter breaking shall amount to not less than 12 Atm Hydrophilic coating of balloon and its shaft Medical devices for carotid artery stenting including one postdilatation balloon must have the following properties: Design of balloon Shaft length of balloon Coating of balloon Diameter of balloons Length of balloons Compatibility with guidewire Compatibility with guidewire catheter Nominal pressure Markers of balloon Balloon shall be of Monorail type or equivalent. More than 130 cm. Hydrophilic coating of balloon and its shaft Spectrum of balloons diameters: from 4.0 to 7.0 mm, with the spacing of 1 mm Range of lengths of balloons 20 and 30 mm inches Compatibility with the guidewire catheter 7F for all the diameters of balloons Nominal pressure of balloon catheter breaking shall amount to not less than 10 Atm Availability of radiopaque markers Page 17

18 Item No Product description Balloon catheter for treatment of carotidcavernous fistula including one guiding catheter must have the following properties: Support External diameter Tip structure Configurations Length Technology Coating Guiding catheter shall ensure active support. The external diameter of the catheter shall amount to 6, 7, 8 F. Tip of the guiding catheter shall be soft, which reduces the risk of blood vessels damage There shall be various available configurations of the catheter s tip Length of the catheter shall amount to 90 and 100 cm. Guiding catheters shall have metal braiding. Availability of hydrophilic coating characterized by antithrombogenic properties. Balloon catheter for treatment of carotidcavernous fistula including one detachable balloon guide microcatheter must have the following properties: Markers Compatibility of microcatheter Length Availability of radiopaque marker within the distal tip. Shall be compatible with guidewire catheters 6 F, 7F and 8F; Shall be compatible for installing at a distal tip of detachable balloon. Necessary total length of not less than 160 cm. Diameter Shall amount to 1.8 F. Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 18

19 Item No Properties of the end segment Coating Product description End segment shall be characterized by increased flexibility. Hydrophilic coating characterized by antithrombogenic properties. Balloon catheter for treatment of carotidcavernous fistula including one detachable balloon must have the following properties: Material Compatibility of balloon Radio-opacity Diameter of balloons Length of balloons Valve of balloon Shall be produced of latex, be characterized by antithrombogenic effect. Shall be compatible with guidewire catheters 6 F, 7F and 8F; Shall be compatible for installing at a delivery microcatheter. Shall have radiopaque marker. Availability of various diameters ranging from 8 to 12 mm depending on the degree of inflation. Availability of various lengths ranging from 11 to 30 mm depending on the degree of inflation. Shall ensure reliable fixation at a delivery microcatheter; Shall ensure repeated inflation and deflation until the moment of controlled separation from the delivery microcatheter; Shall have controlled separation function from the delivery microcatheter; Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 19

20 Item No Product description Shall reliably retain the introduced contrast agent after inflation and separation from the delivery microcatheter. Intracranial stents for the treatment of widenecked cerebral aneurysms must have the following properties: Design Radio-opacity Re-positioning Delivery micro catheter Range of diameters Range of lengths Compatibility with the guidewires Intracranial stent shall be a self-expandable stent; Stent shall be characterized by low profile and be flexible in blood stream Availability of radiopaque markers to control the distal and proximal stent tips Stent shall have a function of re-positioning after removal from the delivery catheter The device shall be compatible with microcatheter for its delivery Availability of the whole spectrum of diameters ranging from 2.5 mm to 4.0 mm Availability of the whole spectrum of lengths ranging from 20 to 30 mm Stent system shall be compatible with the guidewires inches. Balloon catheters for wide-necked cerebral aneurysms must have the following properties: Diameter of balloon catheter Diameter of balloon catheter in inflated state shall be not less than 4 mm Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 20

21 Item No Range of lengths of balloon catheter Hydrophilic property Design of balloon catheter Radio-opacity Product description Length of balloon catheter shall range from 10 mm to 20 mm Balloon catheter shall have a hydrophilic coating Balloon catheter shall have a lateral port for inflation and deflation of balloon, not depending on the main lumen and granting opportunity of independent replacement of the guidewire Shall have radiopaque marker. Medical devices for diagnostic cerebral angiography including one puncture needle must have the following properties: External diameter Compatibility with the guidewire The external diameter of a puncture needle shall amount to not less than 18G Puncture needle shall be compatible with guidewire with the diameter of inches inches Medical devices for diagnostic cerebral angiography including one introducer must have the following properties: Components of introducer Material of introducer Tip of introducer Introducer with hemostatic valve and a lateral port with a 3-way tap, vascular dilator with a port for Luer system syringe, mini guidewire, shutter structure Radiopaque polyurethane with special reinforced structure or equivalent and hydrophilic coating. Availability of radiopaque marker Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 21

22 Item No Dimension Colour coding Product description 5 F and 6F, length of not less than 11 cm. Shall be available Medical devices for diagnostic cerebral angiography including one guidewire must have the following properties: Material Diameter Length Type of distal tip High grade stainless steel. The rod shall have metal braiding. The braiding shall have same diameter throughout the whole length of the guidewire. Guidewire shall have Teflon coating. Guidewire shall have diameter not exceeding inches. Guidewire shall have the length of not less than 150 cm. Tip of the guidewire is available in two configurations: straight and J curved. Medical devices for diagnostic cerebral angiography including one catheter must have the following properties: Distal tip Design of rod Radio-opacity External diameter Catheter shall have soft atraumatic tip that retains the shape. Availability of a braided structure of the catheter rod to avoid kinking and ease of passage. Distal segment of the catheter shall be radiopaque. Catheter shall be characterized by diameters as follows: 5 and 6 F. Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 22

23 Item No. Range of lengths Compatibility of the catheter with guidewires Product description Catheter shall have the length ranging from 65 cm to 100 cm. Catheter shall be compatible with the guidewires with the diameter of inches. Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Catheter tip shape Availability of the whole range of tips of all forms and modifications. Cerebral aneurysm clips must have the following properties: Indication Product s material Pressure of consolidated jaws Jaws length Jaws configuration Fenestrated clips type Range of jaw s opening Jaw s surface Sterilisation Designed for eliminating of arterial cerebral aneurysm from the blood flow in the course of open neurosurgeries Clips shall be made of titanium alloy. Availability of the whole spectrum: for temporary blocking of the carrying arteries ( g/cm 2 ), for permanent elimination of aneurysms from the blood flow ( g/cm 2 ) From 5 to 25 mm Straight, curved in different planes, bayonet Availability of the whole spectrum of configurations of the layer s working part with the fenestrated clips type From 6 to 10 mm Atraumatic, smooth profile, closing surface provides stable fixation of the jaws on the aneurysm neck Possibility of multiple sterilisation Page 23

24 Item No Product description Medical devices to stop bleeding including one soluble hemostatic surgical dressing (size 7.5 х 5 cm) must have the following properties: Properties Sterile, biocompatible, hemostatic cloth, designed to suppress capillary haemorrhages, as well as venous and minor arterial haemorrhages. Composition Oxidized cellulose 100% Dimensions Absorbing capacity Blood clotting time Mechanism of action Absorption time 7.5 x 5 cm Not less than 10mg/1 cm² Not exceeding 2 minutes Oxidized cellulose after contacting blood turns into adhesive gel, which prevents wash out of platelets from the wound and results in swift control of bleeding. While contacting with body fluids / blood it shall not get increased in volume, expand or cause pressure on the surrounding tissues and organs. Is completely biodegradable and is completely absorbed by the body within three days (72 hours). Medical devices to stop bleeding including one soluble hemostatic surgical dressing (size 20 х 10 cm) must have the following properties: Properties Sterile, biocompatible, hemostatic cloth, designed to suppress capillary haemorrhages, as well as venous and minor arterial haemorrhages. Composition Oxidized cellulose 100% Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 24

25 Item No Dimensions Absorbing capacity Blood clotting time Mechanism of action Absorption time Product description 20 x 10 cm Not less than 10mg/1 cm² Not exceeding 2 minutes Oxidized cellulose after contacting blood turns into adhesive gel, which prevents wash out of platelets from the wound and results in swift control of bleeding. While contacting with body fluids / blood it shall not get increased in volume, expand or cause pressure on the surrounding tissues and organs. Is completely biodegradable and is completely absorbed by the body within three days (72 hours). Medical devices for embolization of brain arteriovenous malformations including one implant for embolization of vessels must have the following properties: Implant Porous polymeric cast Radio-opacity Implant for embolization of vessels shall be premixed. Implant for embolization of vessels shall start to harden from the outside and then from the inside, which provides for better penetration into АВМ microstructure. Implant for embolization of vessels shall be able to form porous polymeric cast inside the АВМ Implant for embolization of vessels shall be radiopaque Medical devices for embolization of brain arteriovenous malformations including one Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 25

26 Item No Product description delivery micro catheter must have the following properties Lumen of microcatheter Indication Tip configuration External diameter of distal part Compatibility Total length Microcatheter shall have homogenous lumen for introduction along the guided guidewire into the blood stream Microcatheter is designed for introduction of diagnostic substances, therapeutic agents into the neurovascular system Availability of a detachable tip, with a length not less than 15 mm The external diameter of distal part must not exceed 1.9 F Compatibility with DMSOcontaining substances Total length shall amount to not less than 165 cm Medical devices for embolization of brain arteriovenous malformations including one hydrophilic guide wire must have the following properties Length Diameter Coating Length of the radiopaque segment Length of the guidewire shall amount to not less than 200 cm Diameter of the guidewire shall not exceed inches Guidewire shall have a hydrophilic coating Length of the radiopaque segment shall amount to not less than 10 cm Surgical local hemostatic agents for neurosurgery (hemostatic fiber made of soluble oxidized regenerated cellulose, size 5 х 7.5 cm) must have the following properties: Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 26

27 Item No Material Material characteristics Production Bactericidal activity Dimension Material colour Control (arrest) of bleeding High absorption Delivery form Storage conditions Product description Sterile local haemostatic monocomponent soluble material, based on oxidized regenerated cellulose of plant origin Texiform braiding (braided material) By means of adjustable oxidation of regenerated cellulose Available (with proven bactericidal effect with the broad spectrum of action against grampositive and gramnegative microorganisms including antibioticresistant strains as follows MRSA, MRSE, PRSP, VRE) 5 cm х 7.5 cm (+/- 0.1) cm White with a pale yellow shade Average time amounts to 2-4 minutes. By way of enzymatic hydrolysis during 7-14 days 12 pieces in the box, each piece in individual sterile packaging. The product shall be stored at Surgical local hemostatic agents for neurosurgery (hemostatic cotton wool made of soluble oxidized regenerated cellulose, size 2.5 х 5.1 cm) must have the following properties: Material Material characteristics Sterile local haemostatic monocomponent soluble material, based on oxidized regenerated cellulose of plant origin NONWOVEN fibrous hemostatic structure with seven layers Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 27

28 Item No Bactericidal activity Product description Available (with proven bactericidal effect with the broad spectrum of action against grampositive and gramnegative microorganisms including antibioticresistant strains as follows MRSA, MRSE, PRSP, VRE) Dimension 2.5 cm х 5.1 cm (+/- 0,1) cm Control (arrest) of bleeding High absorption Usage pattern Delivery form Storage conditions Average time amounts to 2-4 minutes. By way of enzymatic hydrolysis during 7-14 days -Universal (swab, «puff», as a whole, in the form of separate layers) -Possibility of spot coagulation without removing material from the wound surface 10 pieces in the box, each piece in individual sterile packaging. The product shall be stored at Surgical local hemostatic agents for neurosurgery (SURGIFLO Hemostatic Matrix Kit) must have the following properties Material Period of complete absorption Material colour Composition Sterile local hemostatic foamy matrix, soluble, based on porcine gelatine 4-6 weeks White with yellow (cream) shade 1. 1 syringe х10-12 ml, prefilled with hemostatic matrix (6 ml), 2. 1 empty sterile syringe х ml, Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 28

29 Item No Length of white tip Length of blue tip Time needed to prepare hemostatic material Time-of-use of the readyto-use product Delivery form Storage conditions Product description 3. 1 tip-applicator (white), 4. 1 flexible tip-applicator (blue) with marker lines, 5. 1 luer adapter for syringe, 6. 1 cup for liquid carryover cm (can be cut to reach the required length) 14.6 cm (with memory) Not more than 1 minute 24 hours Set in individual sterile packaging. The product shall be stored at 2 С - 25 C. Elongated guiding catheter for distal endovascular access Indication Catheter design Catheter wall Distal segment properties Tip structure Is designed for simultaneous distal introduction of two intervention devices into cerebral vessels. Availability of a construction ensuring proximal support, distal softness and flexibility. Reinforced with metal mesh wire. Distal segment shall be flexible and radiopaque with hydrophilic coating. Tip of the guiding catheter shall be soft to ensure reduced risk of trauma while introducing and locating it together with radiopaque marker. Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 29