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 compliment to its existing larger-diameter IVL catheter which has been on the market in Europe since 2015, the company said. The system includes a battery-powered generator and hand-held connector cable and a catheter which houses the lithotripsy emitters within an integrated balloon.
“The treatment of CLI is commonly compounded by the presence of complex medial calcium, deep in the wall of below-the-knee arteries, and clearly remains a significant unmet clinical need based on our customers’ feedback. Representing our commitment to optimizing outcomes and tailoring our IVL therapy for specific use cases across the vasculature, Shockwave S4 was designed specifically to address the challenges of CLI. We look forward to introducing this novel technology over the coming months to provide our clinicians with a tool to help them achieve a high degree of luminal gain with minimal complications and greatly simplify these complex CLI procedures,” CEO Doug Godshall said in a press release.
Last October, Shockwave Medical said that it raised another $35 million for the Lithoplasty devices it’s commercializing to treat blocked arteries.