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SAMDAILY.US - ISSUE OF SEPTEMBER 16, 2023 SAM #7963
SOURCES SOUGHT

65 -- Impella Heart Pump

Notice Date
9/14/2023 10:48:15 AM
 
Notice Type
Sources Sought
 
NAICS
339112 — Surgical and Medical Instrument Manufacturing
 
Contracting Office
260-NETWORK CONTRACT OFFICE 20 (36C260) VANCOUVER WA 98662 USA
 
ZIP Code
98662
 
Solicitation Number
36C26023Q1046
 
Response Due
9/19/2023 12:00:00 PM
 
Archive Date
10/04/2023
 
Point of Contact
Sangmi Kim, Contract Specialist, Phone: (253) 582-8440 ext.75156
 
E-Mail Address
sangmi.kim@va.gov
(sangmi.kim@va.gov)
 
Awardee
null
 
Description
SOURCES SOUGHT NOTICE This is a SOURCES SOUGHT NOTICE (SSN) ONLY. The U.S. Government is conducting market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Business Manufacturers, other Small Businesses interested and capable of providing items requested. There is no business size/socio-economic category restriction (unrestricted/open market) for this Sources Sought Notice. The intended contract is a one (1) year period of performance from 10/01/2023 through 09/30/2024 for up to eight (8) each of the requested items. The Department of Veterans Affairs, NCO20 is looking for the following item: Impella CP Pump Set, US (MFG Part # 0048-0003) (up to 8 each) MUST MEET THE BELOW SALIENT CHARACTERISTICS. The contractor shall furnish up to eight (8) each Impella CP Pump for Puget Sound VAMC. ****SALIENT CHARACTERISTICS OF Impella CP Pump **** A left ventricular assist device (LVAD) in general is a pump that we use for patients who have reached end-stage heart failure. We surgically implant the LVAD, a battery-operated, mechanical pump, which then helps the left ventricle (main pumping chamber of the heart) pump blood to the rest of the body. Typically, this stays with the patient upon release from the hospital. We do NOT want this pump. Our need is for during stent procedures so that after procedure we will turn off the pump and remove it from the Veteran. The Veteran will NOT go home with the pump we are requesting. For our request, more specifically, we require the following: a miniaturized percutaneously inserted ventricular assist device (VAD) that Can be placed via a retrograde approach across the aortic valve using a femoral arterial access. The device pumps blood from the left ventricle into the ascending aorta and systemic circulation at the upper rate of 2.5 L/min. Catheter-based, miniaturized rotary blood pump that affords easy percutaneous access. The device enables immediate and sustained unloading of the left ventricle while increasing the overall systemic cardiac output and supports patients with CS. Left ventricular unloading with this pump device via the transthoracic or femoral approach is feasible and safe. The device will provide a significant level of hemodynamic support and ***does not require a stable electrocardiography (ECG) or blood pressure signal to function properly. FDA approved use for 6 hours, but with current data for off-label use in patients for a variable duration, ranging from a few hours to an average of 12 days, with the longest recorded duration at 35 days in a single documented case. Device is not to be a permanent heart assist measure. a small blood pump at the end of a thin, flexible tube (catheter). This is inserted through a blood vessel in a patient's leg (called the femoral artery). Once implanted, it pumps blood for the left side of the heart. The device can be inserted via a standard catheterization procedure through the femoral artery (through a sheath and guided over a wire), into the ascending aorta, across the valve and into the left ventricle. A camera is then used to guide the device catheter into the left ventricle. The device works by sending blood from the left ventricle to the ascending aorta, which is the main blood vessel leaving the left ventricle. This device is NOT an IABP . And IABP works by using the force of each heartbeat to increase blood flow. We are requesting the device that functions independently of how forceful the heart beats. (see #7 above) Device will pump up to 2.5 liters of blood per minute. This heart pump remains turned on until the stenting procedure is complete. Once appropriate the surgeon will turn off the pump and remove it. The Veteran does not go home with this heart pump. It is primarily for use during stenting procedures. Potential contractors shall provide, at a minimum, the following information to sangmi.kim@va.gov. 1) Company name, address, and point of contact, phone number, e-mail address, and SAM UEI code. 2) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 339112 SURGICAL AND MEDICAL INSTRUMENT MANUFACTURING. To be considered a small business your company must have fewer than 1,000 employees. This notice is to determine the marketplace for this specific requirement. Please check one of the following: [ ] yes [ ] no Service Disabled Veteran Owned Small Business (SDVOSB) [ ] yes [ ] no Veteran Owned Small Business (VOSB) [ ] yes [ ] no Small Business Manufacturers [ ] yes [ ] no All other Small Business (SB) [ ] yes [ ] no Other than Small Business 3) The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM). 4) Any Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the SBA VetCert database at http://veterans.certify.sba.gov. 5) Only authorized representatives/providers of the manufacturer will be considered. Equipment must be new, no used or gray market/refurbished equipment accepted. Please provide a proof of authorized dealer or reseller letter from manufacturer. Responses are due by 9/19/2023 12:00 PM (PT), to the Point of Contact. Point of Contact: Sangmi Kim Contract Specialist sangmi.kim@va.gov (253) 582-8440 ext.75156
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/cb27490c4672469e8d8646c954b213d3/view)
 
Place of Performance
Address: Department of Veterans Affairs Puget Sound Health Care System 1660 South Columbian Way, Seattle 98108, USA
Zip Code: 98108
Country: USA
 
Record
SN06832478-F 20230916/230914230127 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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