L6IVL080030 Shockwave L6 Peripheral IVL Catheter, 7Fr, 8.0mm x 30mm - 110cm. Box of 01

Device Description

• 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