SOURCES SOUGHT
65 -- Philips Phoenix atherectomy system, Tack endovascular system (Delivery for VA Wilmington) Brand Name Only. This is not a request for quote.
- Notice Date
- 8/7/2022 9:58:44 AM
- Notice Type
- Sources Sought
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
- ZIP Code
- 15215
- Solicitation Number
- 36C24422Q1069
- Response Due
- 8/12/2022 9:00:00 AM
- Archive Date
- 11/10/2022
- Point of Contact
- Allan Tabliago, Contract Specialist, Phone: 215-823-5800
- E-Mail Address
-
allan.tabliago@va.gov
(allan.tabliago@va.gov)
- Awardee
- null
- Description
- THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. This Sources Sought Notice is for market research purposes only and shall not be considered an Invitation for Bids, Request for Quotations, or a Request for Proposal. Do not submit a proposal or quote. This market research is issued for information and planning purposes only and does not constitute a solicitation nor does it restrict the Government as to the ultimate acquisition approach. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Additionally, there is no obligation on the part of the Government to acquire any products or services described in this sources sought notice. You will not be entitled to payment for direct or indirect costs that you incur in responding to this Sources Sought Notice. Any contract that might be awarded based on information received or derived from this market research will be the outcome of a competitive process. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. No solicitation exists. Therefore, do not request a copy of a solicitation. See instructions on page 7. Philips Phoenix atherectomy system, Tack endovascular system (Brand Name Only) INTRODUCTION/BACKGROUND: The Phoenix atherectomy system combines the benefits of existing atherectomy systems to deliver a unique atherectomy option to help physicians tailor the treatment approach for each patient. It cuts, captures, and clears diseased tissue with one insertion. Phoenix treats a broad range of tissue types, from soft plaque to calcified arteries, and can be used for lesions above and below the knee. Front cutter clears tissue in a way that may help reduce potential trauma to the vessel. Blades are designed for continuous capture of debulked material. Internal Archimedes screw clears plaque without having to remove the catheter and clean out debulked material. The Tack endovascular system is a dissection repair device that provides precision treatment of peripheral arterial dissections following balloon angioplasty in either above- or below-the-knee therapeutic interventions. OBJECTIVE: The Department of Veterans Affairs, VISN 04, Wilmington VA Medical Center Wilmington, DE hereby referred to as the VAMC Wilmington (460), is requesting the Brand Name only acquisition of the following: See 3.4. Table 1 for requirement MAJOR REQUIREMENTS: The Contractor/Vendor must complete the following tasks to meet the needs of this acquisition: Salient Characteristics Brand Name Philips Healthcare Phoenix rotational atherectomy system Single insertion: no need to remove and clean out debulked material. Low profile, front-cutting design allows for direct lesion access. Atherectomy catheter Distal cutting element rotates at 10,000 - 12,000 RPM Cutting element made of stainless-steel alloy with proprietary carbon coating Battery-powered powered handle operated No capital equipment or additional procedural accessories are required. Powers rotation of cutting element Small, handheld form factor Compatible with all Phoenix catheter sizes IFU recommended maximum run time is 20 minutes Wire support clip Serves as system brake Provides for single user operation Integrated torque clip Debris collection bag External bag collects debulked material as it is continuously captured and cleared from the body Reconnaissance PV .018 OTW See clearly and treat optimally through tip-to-tail improvements. Digital IVUS imaging Assess disease markers, plaque burden percentage, lesion location and morphology, calcium volume, and the presence of thrombus. It also provides analysis of crucial parameters like luminal cross-sectional measurements and aids in disease diagnosis. Provide real-time diagnostic imaging for peripheral artery disease Confirm treatment results, including the completeness of treatment, the apposition and expansion of stent placement, and whether or not the patient requires a thrombolytic drip. Tapered tip, robust shaft, an over-the-wire platform, and longer working length allow for outstanding deliverability, improved workflow, and enhanced image durability. 0.014"" and 0.018"" guide wire compatible 20 mm max imaging diameter TACKS 4F Tack Endovascular System (1.5-4.5mm), 150cm 4F/.014 OTW delivery systems 150 cm working lengths Four (4) pre-loaded Tack implants Self-sizes to tapering vessel diameters from 1.5-4.5 mm with a single system Accurate ( 1 mm) deployment Nitinol with gold radiopaque markers TACKS 6F Tack Endovascular System (4-8mm), 135 cm 6F/.035 OTW delivery systems 135 cm working lengths Six (6) pre-loaded Tack implants Self-sizes to tapering vessel diameters from 4.0-8.0 mm with a single system Accurate ( 1 mm) deployment Nitinol with gold radiopaque markers Technical Specifications Phoenix Atherectomy System-1.5 mm x 149 cm, 4F Catheter Size 1.5 mm tracking Introducer size 4 F(>1.5mm) Working length 149 cm Guidewire compatibility 0.014o Phoenix Atherectomy System-DEFL 2.2mmx 130cm Catheter Size 2.2 mm auto-deflected Introducer size 6 F(>2.2mm) Working length 130 cm Guidewire compatibility 0.014o IVUS Catheter-Reconnaissance PV .018 OTW Minimum guide catheter 5F Maximum imaging diameter 20 mm Frequency 0.071 in Frequency 20 MHz Maximum guide wire 0.018 in Working length 150 cm Tack endovascular system (4F) Tack implant length 6.0 mm Treatment range (RVD) 1.5-4.5 mm Catheter length 150 cm Number of Tacks implants 4 Treatment range 1.5-4.5 mm Tack endovascular system (6F) Tack implant length 6.0 mm Treatment range (RVD) 1.5-4.5 mm Catheter length 135 cm Number of Tacks implants 6 Treatment range 4.0-8.0 mm Table 1 Item No. Part No. Description QTY 0001 018OTW IVUS Catheter-Reconnaissance PV .018 OTW 5 0002 P15149K Phoenix Atherectomy System-1.5 mm x 149 cm, 4F 2 0003 PD22130K Phoenix Atherectomy System-DEFL 2.2 mm x 130cm 2 0004 154150041 TACKS 4F Tack Endovascular System (1.5-4.5 mm), 150 cm 2 0005 206135061 TACKS 6F Tack Endovascular System (4-8 mm), 135 cm 2 The Government and the Contractor understand and agree that the services to be delivered under this contract by the Contractor to the Government are non-personal services and the parties recognize and agree that no employer-employee or master-servant relationships exist or will exist under the contract between the Government and the Contractor s employees. POINT OF CONTACT (POC): The identified POC and technical representative for this acquisition is: Name: Jennifer Coy Phone Number: 302-994-2511x5290 Email: jennifer.coy2@va.gov ""No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification."" REPORTS/DELIVERABLES: Delivery confirmation of equipment and commodities will be made through the Logistics Department of the VAMC Wilmington (460). This will include documentation of receipt and assignment of a facility based EE number for identification and tracking purposes. Delivery confirmation of non-equipment/ commodities acquisitions is the responsibility of the receiving Facility and/ or Service. REQUEST FOR INFORMATION INSTRUCTIONS: The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, UEI Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339112 (size standard of 1000 employees). Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If not, can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers. Does your company exceed 500 employees; Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied; Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; Obtained an individual or class waiver? If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes? Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. Please provide your UEI number. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to allan.tabliago@va.gov no later than, 12:00 PM Eastern Standard Time (EST) on August 12, 2022. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, Allan Tabliago. Questions or responses will include the Source Sought number in the subject line. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. Any interested business concern must submit a no longer that 10-page capability statement addressing its ability to meet the requirements listed above to Capability Statement shall include a statement regarding how the business concern is engaged in wholesale trade and normally sells the item being supplied and how the business concern will take ownership of the items being delivered. Vendors shall also provide certification, evidence that they are an authorized distributor of the Original Equipment Manufacturer. If a solicitation is issued, information will be posted on the SAM web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Officer at allan.tabliago@va.gov. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/10e129c9bb9748e99193146212d35edf/view)
- Place of Performance
- Address: Department of Veterans Affairs Wilmington VAMC 1601 Kirkwood Highway, Wilmington, DE 19805, USA
- Zip Code: 19805
- Country: USA
- Zip Code: 19805
- Record
- SN06417045-F 20220809/220807230103 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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