FastWave Completes Enrollment in FIH Study of Peripheral IVL System

January 17, 2024—FastWave Medical announced the completion of enrollment for the first-in-human (FIH) study of its peripheral intravascular lithotripsy (IVL) technology.

According to FastWave, the peripheral IVL platform is designed to treat calcific artery disease by fracturing calcium deposits using a low-profile, rupture-resistant balloon that generates circumferential ultrasonic pressure.

The prospective single-arm FIH study is assessing the safety and performance of FastWave’s IVL system in patients with peripheral arterial disease of the superficial femoral or popliteal arteries with moderate to severe calcium. The study enrolled eight patients at San Lucas Hospital in Tuxtla Gutiérrez, Mexico.

The FIH study procedures were conducted by Principal Investigators Miguel Montero-Baker, MD, and Venkatesh Ramaiah, MD, in collaboration with the hosting investigator, Antonio Muñoa, MD.

Dr. Montero-Baker is from Houston Methodist Hospital and Hope Vascular & Podiatry Clinic in Houston, Texas. Dr. Ramaiah is from HonorHealth Vascular Group and Pulse Cardiovascular Institute in Scottsdale, Arizona. Dr. Muñoa is a vascular surgeon at San Lucas Hospital as well as Clínica Venart in Tuxtla Gutiérrez.

“I am excited to be part of the initial cases to evaluate FastWave’s peripheral IVL platform,” commented Dr. Montero-Baker in the company’s press release. “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.”

Dr. Ramaiah added, “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. FastWave’s peripheral IVL technology is a promising advancement in calcium modification, and I am excited by the procedural success in these initial cases.”