BOSTON--(BUSINESS WIRE)--Oct 15, 2024--
Amplitude Vascular Systems ( AVS ), a medical device company focused on safely and effectively treating severely calcified arterial disease, announced today that it has enrolled the first patient(s) in its U.S. pivotal trial for Pulsatile Intravascular Lithotripsy (PIVL) therapy. The POWER PAD II clinical study will evaluate the safety and efficacy of AVS's Pulse IVL™ System for the treatment of patients with moderate to severely calcified peripheral arterial disease. Nicolas W. Shammas, MD, FACS, FSCAI, FSVM, conducted the first case at UnityPoint Trinity Medical Center in Bettendorf, Iowa.
AVS received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) in June 2024 to begin POWER PAD II. The trial will enroll up to 120 subjects who will be followed for up to six months at up to 20 U.S. facilities.
"AVS is one of the first companies to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the U.S., and this patient is the first of many U.S. patients who will benefit from our innovative technology," said Elizabeth Galle, Vice President of Clinical Affairs at AVS. "This marks our most significant clinical milestone to date as we approach FDA clearance and market availability for the Pulse IVL™ System. We are confident in our innovative technology, which is designed for easy delivery across complex calcified lesions and can reduce overall procedural costs."
"UnityPoint Trinity Medical Center is proud to enroll the first patient in the POWER PAD II Study and we are grateful for the opportunity to be the first hospital to treat a U.S. patient with this innovative approach to Intravascular Lithotripsy. We found the device to be very deliverable and incredibly efficient at effectively modifying calcium and ultimately restoring blood flow to our patients' vascular system," said Dr. Shammas, who is also President and Director of the Midwest Cardiovascular Research Foundation.
"By introducing a new, innovative treatment for calcified arterial disease, we can make a dramatic impact on patient lives and improve outcomes," said Dr. Chris Metzger, National Principal Investigator of the POWER PAD II Study. "The results of this U.S. pivotal trial will pave the way for a new treatment option in an evolving and exciting area of medicine: IVL therapy."
To learn more about AVS and the PULSE IVL™ System, please visit: www.avspulse.com
About AVS
Amplitude Vascular Systems (AVS) is a medical device company based in Boston, MA, focused on safely and effectively treating severely calcified arterial disease. AVS is backed by global investors including BioStar Capital, Cue Growth Partners, and others. To learn more about pulsatile intravascular lithotripsy, visit www.avspulse.com.The Pulse Peripheral Intravascular Lithotripsy (IVL) System is an investigational device and not yet cleared for commercial distribution within or outside the United States.
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CONTACT: Media:
Matter Health for AVS
Dan Ventresca
T: 617-874-5488
[email protected] Relations:
Susie McAfee
VP of Administration, Marketing and People
T: 904-553-4423
KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: SURGERY MEDICAL DEVICES FDA HOSPITALS CLINICAL TRIALS HEALTH TECHNOLOGY CARDIOLOGY BIOTECHNOLOGY HEALTH
SOURCE: Amplitude Vascular Systems
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PUB: 10/15/2024 07:58 AM/DISC: 10/15/2024 07:58 AM
http://www.businesswire.com/news/home/20241015825546/en