Rotarex Atherectomy System, Kansas City, MO

STATEMENT OF WORK (SOW)

Rotarex for Radiology GENERAL INFORMATION Title of Project: Procurement of the Rotarex Atherectomy System for KC VAMC.

Scope of Work: The vendor shall provide all resources necessary to accomplish the deliverables described in the statement of work (SOW), except as may otherwise be specified.

Background: The Kansas City VA Medical Center Radiology Department provides services to veterans in which the Rotarex Atherectomy System which is used as an atherectomy device and to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.

GENERAL REQUIREMENTS:

New and Unused: Equipment shall be new, unused, produced from current production components, and shall be delivered ready for use.

EQUIPMENT: The Rotarex™ Atherectomy System is made up of a single use Rotarex™ Atherectomy Catheter Set and the Drive System, consisting of the Control Unit, Motor and Footswitch. The Rotarex™ Atherectomy Catheter Set is composed of multiple components, including the Rotarex™ Atherectomy Catheter, supplied guidewire, collecting bag, and sterile drape.

Rotarex™ Atherectomy Catheters are over-the-wire, single use, percutaneous devices for the removal of atheromatic plaque and thrombi from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses. The catheters are latex and phthalate free, and consist of a flexible outer covering, a rotating head, and a rotating helix which runs the length of the catheters.

A lumen for the passage of the supplied guidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings. The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft.

The helix and the catheter head rotate at approximately 40,000-60,000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with abrading facets at its foremost tip. The Rotarex™ Atherectomy System Guidewires are 0.018" and are included with each Rotarex™ Atherectomy Catheter Set. These supplied guidewires consist of a Nitinol core and a PTFE coating with a 9.5 cm hydrophilic distal coating and a 4 cm angled flex tip.

WARRANTY: The manufacturing warranty is for 1 year and that one-year manufacturing warranty starts when the device is first shipped to the customer. If any issues occur during that first year after they’ve purchased the device, they will coordinate getting the device return for service and would not be billed for any shipping, parts, or labor to repair the device.

If the failure occurs after that 1st year, the device would not be under warranty, and they would have to pay for shipping and that came due outside of warranty. Vendor will provide loaners if needed at no cost to the customer while their device is still under a manufacturing warranty. If not under warranty, the loaner cost is $200 a month. The drive system does not require yearly maintenance.

DELIVERY & LOCATION INFORMATION:

Kansas City VA Medical Center Attention: X-Ray M2-417 4801 East Linwood Boulevard Kansas City, MO 64128-2226