FastWave Medical announced the successful completion of enrollment for its first-in-human study of its peripheral intravascular lithotripsy (IVL) system to treat calcified cardiovascular disease.
Dr. Miguel Montero-Baker of Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah of HonorHealth Vascular Group and the Pulse Cardiovascular Institute successfully conducted the procedures with the hosting investigator, Dr. Antonio Muñoa.
“I am excited to be part of the initial cases to evaluate FastWave’s peripheral IVL platform. Their team has rapidly developed an easy-to-use system to address existing technological gaps, marking a significant milestone in achieving the company’s near-term goals,” Montero-Baker said in a news release.
Minneapolis-based FastWave’s IVL platform is meant to treat calcific artery disease by fracturing calcium deposits with a balloon catheter that delivers shock waves. The company says its peripheral IVL technology offers a user-friendly design with a deliverable, low-profile, rupture-resistant balloon. The system delivers durable and predictable circumferential ultrasonic pressure to fracture calcium.
“Calcium poses significant therapeutic challenges in treating peripheral artery disease, and many of the existing modalities are not optimal for addressing medial and deep plaque,” Ramaiah said. “FastWave’s peripheral IVL technology is a promising advancement in calcium modification, and I am excited by the procedural success in these initial cases.”
FastWave Medical co-founder and CEO Scott Nelson congratulated the team behind the technology on reaching the milestone in less than three years of forming the company: “The successful enrollment of our FIH study is an important inflection point for FastWave, and we’re looking forward to advancing our peripheral IVL system toward a pivotal clinical trial this year.”
About four months ago, the company closed an oversubscribed, multi-million-dollar private financing round.