BOSTON--(BUSINESS WIRE)--AVS (Amplitude Vascular Systems, Inc), an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease with its PIVL™ therapy, announced today it will present data from its POWER PAD I clinical trial at the Transcatheter Cardiovascular Therapeutics (TCT) conference, the Cardiovascular Research Foundation's (CRF) annual scientific symposium.
Jon George, MD, a medical advisor to AVS and interventional cardiologist at Pennsylvania Hospital, University of Pennsylvania Health System, will present the abstract during the Peripheral Vascular Intervention Techniques session on Wednesday, Oct. 25, 2023. The presentation titled "Pulse Intravascular Lithotripsy to Open Vessels with Calcific Walls and Enhance Vascular Compliance and Remodeling: First-in-Human Cases from the POWER PAD I Study" will showcase findings from AVS’s first-in-human study with its PULSE™ IVL System.
“By demonstrating an ability to reduce pain, increase blood flow and improve patients’ ability to walk, the PULSE IVL System is creating a new treatment option for patients with calcified artery disease,” said Dr. George. “The results of the study show we can successfully treat patients with multiple peripheral lesions using a single device. We believe this is also a step toward proving the device’s effectiveness in treating coronary artery disease.”
Dr. George's presentation focuses on the innovative work conducted as part of the POWER PAD I study. The trial aimed to evaluate the safety and performance of the PULSE IVL System when used in conjunction with adjunctive therapy for the treatment of subjects with calcific femoropopliteal arteries.
“The POWER PAD I clinical trial results represent groundbreaking data for the future of pulse intravascular lithotripsy,” said Robert Chisena, Ph.D., Chief Technology Officer at AVS. “We are honored to present these new findings at the TCT Conference, the world’s premier conference for cardiovascular data unveiling.”
The TCT conference has served as a premier showcase of cutting-edge educational content in interventional cardiovascular medicine for over three decades. It attracts interventional cardiologists, radiologists, clinical cardiologists, scientists, surgeons, nurse practitioners, and others with a special interest in the field of interventional and vascular medicine. The conference will be held Oct. 23 to 26 at the Moscone Center in San Francisco.
POWER PAD I is a prospective, single-arm, multi-center feasibility study to evaluate the technical and clinical success of the PULSE IVL System for treating patients with calcific femoropopliteal arteries. The trial has enrolled nine subjects who will be followed for 12 months.
To learn more about AVS and the PULSE IVL™ System, please visit https://www.avspulse.com.
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. It is redefining interventional therapy for severely calcified lesions with the 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.