Shockwave C2+ Coronary IVL Catheter

Primary DI

00195451000447

Basic UDI-DI Code

00195451C2KIVLXX

Reference

C2KIVL3512

Device Types

Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 3

Status

On The Market

The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2+ Coronary IVL Catheter is compatible with a 5F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery. The IVL Catheter Rx port is located at 27 cm from the distal tip.

The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary IVL Catheter is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic de novo coronary arteries prior to stenting.

The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDR).