ANN ARBOR, Mich.–(BUSINESS WIRE)–AVS, an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease with its PIVL™ therapy, today announced 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.
“This trial serves an important patient population with limited treatment options, and I am encouraged by the early results of the first patients,” stated Dr. Jon George, Interventional Cardiologist and Endovascular Medicine Specialist at Pennsylvania Hospital, Philadelphia. “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.”
“We are excited by this first-in-human trial milestone we have achieved,” added Mark Toland, President and Chief Executive Officer of AVS. “Successful enrollment of multiple patients by several operators around the world, coupled with event-free, 30-day results of the first patients, provides us with confidence that our PIVL therapy has the potential to be another effective tool for treating severely calcified arterial disease. We believe that peripheral arterial disease is only the beginning of where this technology may benefit patients.”
Additionally, the company announced the appointment of William H. (Hank) Kucheman, former Chief Executive Officer for Boston Scientific Corporation, 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. Mr. Kucheman earned his BS and MBA from Virginia Polytechnic Institute and State University. “I am thrilled to welcome Hank to our Board of Directors,” said Toland. “His depth of expertise in the medical technology sector will strengthen our capabilities as we continue to develop this technology and build on our promising foundational evidence.” Kucheman added, “I am delighted to join the AVS board and look forward to helping patients with limited treatment options. This is important work, and I’m excited to be part of the team.”
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. To learn more about pulsatile intravascular lithotripsy, visit www.avspulse.com.
The Pulse Peripheral Intravascular Lithotripsy (IVL) System is in development. It is not yet cleared for commercial distribution in any country. Its future availability cannot be guaranteed.