S4 Peripheral IVL Catheter Instructions for Use Rev B June 2018

Instructions for Use

7 Pages

Peripheral Intravascular Lithotripsy (IVL) Catheter Instructions for Use (IFU) For use with the Shockwave Medical, Inc. IVL Generator and Connector Cable  Indication for Use The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature. Contents: Shockwave S4 Peripheral IVL Catheter o The following balloon diameters are available: 2.5mm, 3.0mm, 3.5mm, 4.0mm o Folded balloon diameters are: 0.052” max for 2.5mm and 3.0mm, and 0.054” max for 3.5mm and 4.0mm o 40mm balloon length o 135cm catheter working length o 2.5 – 4.0mm balloon is 5 Fr. introducer sheath compatible o 0.014” (0.36mm) guidewire compatible (OTW - 300cm wire) How Supplied The IVL Catheter is supplied sterile via e-beam sterilization. The IVL Catheter is intended for single use only and is not intended for reuse or resterilization. Carefully inspect all packaging for damage or defects prior to use. Do not use the device if any sign of damage or breach of the sterile barrier is observed as this could lead to malfunction of the device and/or injury to the patient. Store the IVL Catheter in a cool, dark, dry place. Storage of the device in extreme conditions may affect device performance and lead to patient injury. 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 comprises an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy and an integrated balloon. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 2.5 x 40mm, 3.0 x 40mm, 3.5 x 40mm, and 4.0 x 40mm. The S4 Peripheral IVL Catheter is compatible with a 5Fr sheath and has a working length of 135cm. Refer to Figure 1 below for IVL Catheter components.  Figure 1: Shockwave S4 Peripheral IVL Catheter The Shockwave S4 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 and contains a hydrophilic coating designed to increase lubricity during advancement of the catheter to the treatment site. 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. Required Devices for the IVL Procedure The IVL Catheter is to be used exclusively with the IVL Generator and its accessories. Refer to the Shockwave Medical, Inc. IVL Generator and Connector Cable Operator’s Manual for preparation, operation, warnings and precautions, and maintenance of the IVL Generator and IVL Connector Cable.  LBL 61959, Rev. B Instructions for Use (June 2018)  EN  Page 1 of 6
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