POWER CAD I Feasibility Study Begins for Pulse Coronary IVL System From AVS, Now Part of Stryker

May 18, 2026—Amplitude Vascular Systems (AVS), a medical device company focused on treating severely calcified arterial disease, announced the enrollment of the first patient in its first-in-human (FIH) study of its Pulse device for pulsatile intravascular lithotripsy (IVL) therapy in a coronary indication.

AVS noted it has been acquired by Stryker, which recently announced completion of the transaction. In April, Stryker announced the signing of a definitive agreement for the acquisition.

According to AVS, 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. The study will enroll up to 15 patients at up to four facilities in Australia and New Zealand. Primary endpoints will be assessed at 30 days.

The Principal Investigator of the POWER CAD I study is Associate Professor Robert Gooley, MD, who is Deputy Director and Head of Interventional Cardiac Services at Monash Health in Melbourne, Australia.

The first procedure in the study was performed by Jithendra Somaratne, BHB, MBChB, an interventional cardiologist at Auckland City Hospital and The Heart Group in Auckland, New Zealand.

“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,” commented Dr. Somaratne in the company’s press release. “We found the device to be very deliverable and incredibly efficient at modifying calcium and ultimately enabling maximal stent expansion.”

Prof. Gooley added, “A new, innovative treatment for calcified coronary artery disease can make a meaningful impact on patient lives and improve outcomes. 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.”