6515--Intent to Sole Source Shockwave Catheters 528-23-1-4602-0094

Subject: VHA Buffalo Medical Center SHOCKWAVE Medical Intravascular Lithotripsy

STATEMENT OF WORK (SOW)

1. Contract Title. SHOCKWAVE Medical Intravascular Lithotripsy, IVL OTW catheters

2. Background. The Cardiac Catheterization Lab is requesting the purchase of the Shockwave IVL catheters for the continued use of the SHOCKWAVE medical device that delivers sonic pressure through the catheter to crack both medial and intimal calcium while minimizing trauma to the vessel wall. The IVL catheter is delivered across calcified lesion and the integrated balloon is expanded to 4atm to facilitate efficient energy transfer. This system allows safe and effective deployment of left main, LAD, proximal high- risk lesions stents. The VA Medical Center of Buffalo, NY currently provides best practices to our patients and with the catheters and use will continue.

3. Scope.

The purchase of the Shockwave IVL catheters allows percutaneous coronary intervention of calcified lesions. The Shockwave system meets the specific demands of calcified acute coronary lesions, treatment of distal lesions, chronic total occlusions and 3 vessel disease, and stent thrombosis is a rare event. These catheters are the only catheters that allow the IVL system to work. The device and catheters have been FDA approved and in use in our VA HCS.

1

Shockwave C2 IVL Catheter 2.5 x 12mm - C2IVL2512

3

2

Shockwave C2 IVL Catheter 3.0 x 12mm - C2IVL3012

3

3

Shockwave C2 IVL Catheter 3.5 x 12mm - C2IVL3512

7

4

Shockwave C2 IVL Catheter 4.0 x 12mm - C2IVL4012

9

5

IVL Cable Sleeves (10 pack)

3

4. Requirements.

Compatible with SHOCKWAVE DEVICE

4.1 SERVICE - The Buffalo VA Medical Center requires that vendors can provide the following services and information about the SHOCKWAVE IVL catheters.

Vendors must provide educational resources to facility and end users of the product.

Vendor must have 24hr service support center available.