Stryker completed its acquisition of AVS, worth up to $835 million, earlier this month. The company develops intravascular lithotripsy (IVL) technology for treating severely calcified arterial disease.
Now, the company reports the enrollment of the first patient in its first-in-human (FIH) study. It evaluates the company’s pulsatile intravascular lithotripsy (PIVL) therapy in a coronary indication. The POWER CAD I study assesses the feasibility of the Pulse IVL system in 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.
Stryker expects the study to enroll up to 15 subjects at up to four facilities in Australia and New Zealand. They expect primary endpoints assessment at 30 days.
The AVS IVL platform uses pulsed CO₂-generated pressure waves delivered uniformly through an IVL balloon catheter. This process fractures calcium and optimizes luminal gain while enhancing catheter delivery, treatment speed and therapy efficiency.
Tim Lanier, president, Stryker’s Peripheral Vascular division, said:
“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. 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.”
