Shockwave Medical, Inc. L6IVL090030 Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable.