Shockwave's Intravascular Lithotripsy BTK Catheter Launched in Europe

April 23, 2018—Shockwave Medical, Inc. announced CE Mark approval and the European launch of its Shockwave S4 peripheral intravascular lithotripsy (IVL) catheter. Shockwave S4 is a low-profile catheter specifically designed to access and treat challenging calcified lesions in below-the-knee (BTK) arteries frequently associated with critical limb ischemia (CLI). The device is currently only commercially available in Europe and New Zealand.

The Shockwave S4 device complements the company's existing larger-diameter IVL catheter for the treatment of calcified peripheral disease from the iliac arteries down to the knee. The larger-diameter device is commercially available in Europe and the United States.

The Shockwave S4 IVL system features design improvements that enhance deliverability in small distal vessels. These include a longer hydrophilic shaft, a lower crossing and tip profile, smaller lithotripsy emitters, and new, stronger balloon material.

Similar to other IVL systems, Shockwave S4 includes a compact, battery-powered generator, a simple and quick handheld connector cable with a single therapy delivery button, and an intuitive catheter that houses an array of lithotripsy emitters enclosed in an integrated balloon. The catheter is delivered to a lesion similar to standard interventional techniques.

According to the company, IVL treats calcified leg artery blockages with sonic pressure waves. Lithotripsy, which has been used to treat patients with kidney stones, minimizes trauma within the artery by delivering pulsatile sonic pressure waves locally that fracture calcium inside the artery wall but pass through surrounding soft vascular tissue in a safe manner.

In Shockwave Medical's announcement, Professor Marianne Brodmann, MD, of the Medical University of Graz in Graz, Austria, commented, "The new Shockwave S4 IVL catheter has the potential to change the treatment paradigm for our most difficult-to-treat patients—those with CLI. Acute and long-term outcomes for these patients remain poor, especially for patients with vascular calcification who have a five-fold greater risk of major amputation."

Prof. Brodmann added, "Vascular calcium is prevalent in CLI patients and frequently resides deeper in the artery wall, making endovascular treatment more challenging. IVL has the potential to reach and safely treat this deep-wall calcium, thereby improving the ability to open these vessels in an effective and predictable manner, while still preserving future treatment options.”

As noted in the company's press release, IVL has been demonstrated to be a safe and effective treatment for femoropopliteal arteries in the DISRUPT PAD I and II studies and for infrapopliteal BTK arteries in the DISRUPT BTK study, which demonstrated the feasibility of IVL BTK. Acute performance in a patient population with advanced peripheral artery disease, most experiencing critical limb ischemia, showed low residual stenosis and low vascular complications, including no perforations, distal embolization, reflow complications, or abrupt closure, and only one grade B dissection. There were no major adverse events including death, myocardial infarction, target limb revascularization, or amputation through 30 days, advised Shockwave Medical.