M5PIVL4060 Shockwave M5+  Peripheral IVL Catheter,  4.0mm x 60mm - 135cm. 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 integrated 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 nine (9) sizes: 3.5 x 60mm, 4.0 x 60mm, 4.5 x 60mm, 5.0 x 60mm, 5.5 x60mm, 6.0 x 60mm, 6.5 x 60mm, 7.0 x 60mm, and 8.0 x 60mm.
• The M5+ IVL Peripheral Catheter is compatible with a 6 or 7F sheath and has a working length of 135cm. Refer to Figure 1 below for IVL Catheter components.
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Shockwave M5+ Peripheral IVL Catheter

• The Shockwave M5+ 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 0.014” guidewire to facilitate advancement of the catheter to and through the target stenosis.
• The system is designed as ‘Over-the-wire’ (OTW) with 135cm 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.