Shockwave wins CE Mark for S4 peripheral lithotripsy catheter

Shockwave Medical said today it won CE Mark approval in the European Union for its Shockwave S4 peripheral intravascular lithotripsy catheter.
The Shockwave S4 is a low-profile catheter designed to treat calcified lesions below-the-knee arteries, which can be challenging to access and treat, and are often associated with critical limb ischemia.
The company’s Lithoplasty devices are designed to use sound waves to break up calcified lesions blocking blood vessels. Shockwave said the technology is designed to minimize trauma to the artery by delivering pulsatile sonic pressure waves locally that fracture the calcium but safely pass through soft vascular tissue.
“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. Vascular calcium is prevalent in CLI patients and frequently resides deeper in the artery wall, making endovascular treatment more challenging. Intravascular Lithotripsy 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,” Dr. Marianne Brodmann of the Medical University of Graz said in a prepared statement.
The newly cleared S4 is a compli...

Source: Mass Device - April 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Catheters Regulatory/Compliance Vascular Shockwave Medical Source Type: news