AVS Begins POWER PAD I Trial of Pulse IVL Therapy

September 15, 2022—AVS, an early-stage medical device company focused treating severely calcified arterial disease with its Pulse intravascular lithotripsy (IVL) therapy, announced the initiation of enrollment, successful treatment, and positive 30-day follow-up data in the POWER PAD I clinical trial.

According to the company, POWER PAD I is a first-in-human, prospective, single-arm, multicenter feasibility study of the technical and clinical success of the AVS Pulse IVL system for treating patients with calcific femoropopliteal arteries.

The Pulse IVL system uses pressure waves in frequent bursts to restore blood flow to blockages in the legs caused by severe calcium buildup. AVS developed pulsatile IVL to be delivered through the balloon-based Pulse platform. The Pulse IVL platform is designed to gently shatter calcium and open the artery using a single device, noted the company.

AVS advised that patients with multilesion vessel disease that restricted their daily activities were enrolled in POWER PAD I at vascular centers around the world. The trial will enroll up to 20 patients who will be followed for 12 months.

Initial procedures in the study were performed by endovascular surgeon Nelson Encarnación, MD, at Centro Medico Moderno MCA in Santo Domingo, Dominican Republic. Dr. Encarnación was assisted by Jon George, MD, who is an interventional cardiologist and endovascular medicine specialist at Pennsylvania Hospital in Philadelphia, Pennsylvania.

Additional patients were treated by Professor Patrice Mwipatayi, MD, a vascular surgeon at Royal Perth Hospital in Perth, Australia.

“This trial serves an important patient population with limited treatment options, and I am encouraged by the early results of the first patients,” commented Dr. George in the company’s press release. “We have successfully demonstrated that we can treat patients with multiple lesions using a single device, while patients experienced a noted reduction in leg pain, increase in blood flow to the leg, and improvement in their ability to walk.”

The company also announced the appointment of William H. (Hank) Kucheman to its Board of Directors as a representative of BioStar Capital, where he serves as a Managing Director. He is a former Chief Executive Officer for Boston Scientific Corporation and Executive Vice President and President of the Cardiology, Rhythm, and Vascular Group of Boston Scientific.