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Contract Opportunity

Sources Sought Notice
The Department of Veterans Affairs Network Contracting Office 2 is issuing this Sources Sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for Lease of the Excimer Laser System at the VA NYHHS Manhattan Campus Surgical Service 423 East 23nd Street New York, NY 10010. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 532490.
THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.
STATEMENT OF WORK

STATEMENT OF WORK FOR
EXCIMER LASER RENTAL

Introduction/Background

The VA New York Harbor Healthcare System is dedicated to providing quality health care and security to veterans using the abilities of all employees supported by our commitment to education and research.

The Excimer Laser System is used to extract infected pacer leads as an alternative to sternotomy and exploratory cardiotomy. Philips Spectranetics manufacture and markets the only Excimer Laser System approved in the United States for use in minimally invasive interventional procedures within the cardiovascular system. The Philips Spectranetics CVX-300 excimer laser in conjunction with proprietary optical fiber catheters is the only excimer laser system approved for use in the removal of cardiac pacemaker and defibrillator leads. An excimer laser produces pulsed bursts of ultraviolet (UV) light energy that are capable of vaporizing plaque and calcium into tiny particles, the majority of which are smaller than a red blood cell, that are easily absorbed into the blood stream. This energy is transmitted along flexiglass fibers encased in catheters, which can be passed through arteries and veins. The UV light energy is then focused on the blockages that need to be treated.

The Excimer CV Laser is currently on site at the VA NY Harbor Healthcare System.

Objectives

The VA NYHHS Manhattan Campus is requesting a base year plus 2 option year, flat-rate rental agreement for the Philips Spectranetics CVX-300 excimer laser for the removal of cardiac pacemaker and defibrillator leads.

Requirements

The Phillips/Spectranetics LASER system (and GlideLight/CavaClear extraction sheaths) is the only non-mechanical option for transvenous lead extraction, IVC filters, and other chronic foreign bodies. This is the only laser atherectomy option available for patients with large thrombus burden during acute myocardial infarction and patients with calcified disease behind acutely placed coronary stents. This equipment is required for coronaries and peripheral vascular cases as well as devise extraction there are no other alternatives.
The excimer laser is a pulsed laser with the following specifications:

Active medium: XeCI
Wavelength: 308NM
Catheter Output Fluence: 30-80 mJ/mm
Repetition Rate Range: 25 80 Hz
Pulse Width: 125-200 ns, FWHM
Weight: 560 lbs/295 kg
Length: 49 in/ 125 cm
Height: 35 in/ 89 cm- unit
7-9 in/ 18-2 cm control panel
Width: 25 in/ 62 cm
Power Requirements: 200-230V ~ Single Phase
50/60 Hz
16 Amp

Environmental Specifications

Operating Temperature: 12 C to 30 C (54 F to 86 F)
Storage temperature: 0 degrees C to 60 degrees C (32 F to 140 F)
Operating Humidity: 5 to 95% relative humidity, non-condensing
Storage Humidity: 5 to 95% relative humidity, non-condensing

System footswitch is IPX8 rated

Accessories: power cord, footswitch, interlock plug, safety glasses and Spectranetics approved fiber optic catheters

Period of performance: Base year plus two (2) option years

Other Requirements:

The vendor shall be responsible for determination of and compliance with federal and state or local shipping requirements and other factors necessary to ship items at the desired locations.

Place of Delivery

The products will be delivered at the following sites:

VA NYHHS Manhattan Campus
Surgical Service
Attn: Stanley Read
423 East 23nd Street
New York, NY 10010

Security

This equipment does not store patient information or connect to the VA computer system.

Acceptance Procedures

Prior to acceptance of the goods or services provided under this contract, inspection and testing will be performed by the Government in accordance with this clause. (a) Upon delivery the toners shall be turned over to the hospital for use. The contractor shall furnish, upon completion of installation, a written notice of readiness for inspection for the Contracting Officer or the COR when applicable.

Recalls

The Vendor shall immediately notify all affected VA Medical Centers and designated POC in the event of a instrument recall, removal, required adjustment, or required modification that is suggested or mandated by the Vendor, distributor, manufacturer, or any regulatory or government agency. The following information shall be included in this notification:

A complete item description and identification (to include lot and serial numbers where applicable);
Administrative identification data including order numbers and order date;
Reasons for recall, removal, adjustment, or modification; and
Instructions for appropriate corrective action.

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