S02 Attach 01 SON Bard Rotarex.docx

VA Pittsburgh Healthcare System (VAPHS)

STATEMENT OF NEED AND GENERAL SPECIFICATIONS

FOR

Rotarex Rotational Excisional Atherectomy System

1. Background With COVID restrictions lifting and more patients being seen at the VA of Pittsburgh our Vascular Surgical Teams have seen an influx of Peripheral Vascular cases. With keeping to the promise of providing the best possible care for our aging veterans we are requesting a Rotational Excisional Atherectomy System for our Operating Department.

Peripheral Vascular Disease is not typical fatal, however if left untreated more serious problems will occur that are life threating and or fatal. Current techniques to treat this disease included medication as a first encounter. However, when medication does not work the next step is a cumbersome surgical procedure that would involve invasively entering the patients’ blood vessels to install an expansion balloon the widen the area then to apply a semi to permeant implant stent.

The Rotarex Rotational Excisional Atherectomy system allows the surgeon to use minimally Invasive techniques that do not require the insertion of either an expansion balloon or surgical stent implant. This system acts as an internal tunneling system that scraps away any plague or lesions with a highspeed boring motion that tunnels through the blockage and frees the vessels versus stretching them.

2. Specifications One Fully Function Rotational Excisional Atherectomy System

· A minimum of a 6F and 8F Catheter

· Rotational speeds up to 40,000 rpms with an 8F Catheter

· Rotational speeds up to 60,000 rpms with a 6F Catheter

· Tabletop sized power source

· Internal Auto-Aspirating Capabilities

Equipment needed:

80300 Bard Rotarex Drive System 80237 Bard Rotarex Set 6F 135cm 80239 Bard Rotarex Set 8F 110cm

The Rotarex Atherectomy System is designed to efficiently remove both plaque and thrombus by utilizing three distinct mechanisms of action to treat PAD lesions including in-stent restenosis. The device modifies, excises, and aspirates complex lesions with mixed plaque morphology with two different size options—6F & 8F. This unit is used to control bleeding at incision sites by providing hemostatic sealing at the time of the incision.

3. Delivery Location Delivery should be coordinated with the COR of the contract prior to shipping of any equipment

UD Delivery VA Pittsburgh Healthcare System University Drive C, Room 2A118 Pittsburgh PA 15240

The Contractor must comply and provide all necessary information to VAPHS. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government.

Normal business hours for acceptance of deliveries are 8:00am-3:30pm, Monday thru Friday excluding Federal Holidays. Deliveries must be coordinated in advance with COR once a ship date is established. The COR, Biomedical Engineering and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. The VA-issued purchase order number must be included in the packing slip. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the COR. Failure the coordinate shipment with COR, may result in failure to deliver on site and cause re-scheduling of delivery/freight at no charge to the government. The packing slip must include the VA-issued purchase order number

4. Additional Charges

There will be no additional charges with the waste management protocol listed in section 8.