AVS Announces Multi-Site Enrollment of First Patients in POWER PAD I Clinical Trial
16 September 2022 - - US-based medical device company AVS has posted enrollment, successful treatment, and positive 30-day follow up data of the first patients in the POWER PAD I clinical trial.

AVS is only the second company to conduct a first-in-human study in the rapidly growing intravascular lithotripsy space.

Patients with multi-lesion vessel disease that restricted their daily activities were enrolled at vascular centers across the world.

Initial procedures were performed in the Dominican Republic by Dr. Nelson Encarnación, Endovascular Surgeon, at Centro Medico Moderno MCA, with assistance from leading interventional cardiologist, Dr. Jon George.

Additional patients were treated in Australia at Royal Perth Hospital by Professor Patrice Mwipatayi, Vascular Surgeon, who has experience with clinical trials using an alternative intravascular lithotripsy device.

The PULSE IVL System is a novel therapy that uses pressure waves in frequent bursts to restore blood flow to blockages in the legs caused by severe calcium buildup.

AVS is the first company to develop pulsatile intravascular lithotripsy, a therapy that is delivered through a balloon-based platform called PULSE.

The PULSE IVL platform is the only minimally invasive technology that is designed to gently shatter calcium and open the artery using a single device.

POWER PAD I is a prospective, single-arm, multi-center feasibility study to evaluate the technical and clinical success of the AVS PULSE Peripheral Intravascular Lithotripsy System for treating patients with calcific femoropopliteal arteries.

The trial will enroll up to 20 subjects who will be followed for 12 months.

Additionally, the company appointed William H. Kucheman, former chief executive officer for Boston Scientific Corp., to its board of directors as a representative of BioStar Capital.

Before being named CEO, he was executive vice president and president of the Cardiology, Rhythm and Vascular Group of Boston Scientific.

He brings over 35 years of medical device experience, including FDA regulation, commercialization, reimbursement, and clinical marketing.

He currently serves as a Managing director at BioStar Capital, a global team of visionary healthcare investors, and on the boards of several public and non-public companies. He has served on several industry boards, including the Global Health Exchange and Hill-Rom.

AVS is an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease.

It was founded in 2018 by Hitinder Gurm, M.D., Interventional Cardiologist and Chief Clinical officer at University of Michigan, and Robert Chisena, Ph.D., chief technical officer at AVS. We are redefining interventional therapy for severely calcified lesions with our Pulse IVL System, which uses a novel pulsatile mechanism of action to shatter calcium and expand narrowed vessels, all with a single device.

The Pulse Peripheral Intravascular Lithotripsy System is in development. It is not yet cleared for commercial distribution in any country.