AVS, Now Part of Stryker, Enrolls First Patient in First-in-Human Coronary Intravascular Lithotripsy Study

POWER CAD I study will evaluate feasibility of the Pulse IVL™ system in patients with severely calcified coronary arterial disease

BOSTON--(BUSINESS WIRE)--Amplitude Vascular Systems (AVS), a medical device company recently acquired by Stryker and focused on treating severely calcified arterial disease, today announced the enrollment of the first patient in its first-in-human (FIH) study for Pulsatile Intravascular Lithotripsy (PIVL) therapy in a coronary indication.

The POWER CAD I study will evaluate the feasibility of the Pulse IVL™ System for the treatment of patients with moderate to severely calcified coronary arterial disease. Dr. Jithendra Somaratne, interventional cardiologist at Auckland City Hospital and The Heart Group in Auckland, New Zealand, conducted the first case. The study will enroll up to 15 subjects at up to four facilities in Australia and New Zealand, with primary endpoints assessed at 30 days.

“AVS is the only intravascular lithotripsy company to utilize a unique hydraulic mechanism of action, and this is the first step in understanding the patient population that may be able to benefit from our innovative technology,” said Tim Lanier, President, Stryker’s Peripheral Vascular division. “This marks a significant clinical milestone for us as we aim to expand the application of our technology to coronary disease. We are confident our Pulse IVL system, which is designed for easy delivery and efficient treatment of complex calcified lesions, can help elevate care in the IVL space.”

“The team at Auckland City Hospital is proud to enroll the first patient in the POWER CAD I FIH study, and we are grateful to be the first hospital to treat a patient with coronary calcific disease with this innovative approach to Intravascular Lithotripsy,” Dr. Somaratne said. “We found the device to be very deliverable and incredibly efficient at modifying calcium and ultimately enabling maximal stent expansion.”

“A new, innovative treatment for calcified coronary artery disease can make a meaningful impact on patient lives and improve outcomes,” said Associate Professor Robert Gooley, MD, Deputy Director and Head of Interventional Cardiac Services at Monash Health in Melbourne, Australia, and Principal Investigator of the POWER CAD I Study. “Our goal is for the results of this FIH study to pave the way for a new treatment option in an evolving and exciting area of medicine: IVL therapy.”

About AVS

Amplitude Vascular Systems (AVS) is a medical device company based in Boston, MA, focused on treating severely calcified arterial disease. AVS was recently acquired by Stryker, with the deal officially closing on May 7, 2026. To learn more about pulsatile intravascular lithotripsy, visit www.avspulse.com.The Pulse Coronary Intravascular Lithotripsy (IVL) System is an investigational device and not yet cleared for commercial distribution within or outside the United States.

About Stryker

Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside our customers around the world, we impact more than 150 million patients annually. More information is available at www.stryker.com.