FastWave’s IVL System FIH Study Reveals 30-Day Data

May 29, 2024—FastWave Medical announced the 30-day results of its first-in-human (FIH) study using the company’s peripheral intravascular lithotripsy (IVL) technology.

The company stated that the prospective, single-arm, FIH study assessed the safety and feasibility of the FastWave IVL system in eight patients with peripheral arterial disease affecting the superficial femoral artery (SFA) and popliteal artery with moderate to severe calcium. In January 2024, the company announced completion of enrollment in the study.

According to the company, the procedural findings include 100% procedural success, 0% periprocedural adverse events, and 5.9% mean residual diameter stenosis post therapy.

The 30-day results included 0% major adverse events, 100% patency with < 2.4 peak systolic velocity ratio, and 0% revascularization. Walking Impairment Questionnaire scores showed improved walking distance and speed, as well as stair-climbing ability. Additionally, ankle-brachial index improved from 0.56 at baseline to 0.89 at 30 days.

FastWave stated the procedures were conducted at San Lucas Hospital in Tuxtla Gutiérrez, Chiapas, Mexico, by Principal Investigators Miguel Montero-Baker, MD, and Venkatesh Ramaiah, MD, in collaboration with the hosting Investigator, Antonio Muñoa, MD, who is a vascular surgeon at San Lucas Hospital. Dr. Montero-Baker is with Hope Vascular & Podiatry Clinic in Houston, Texas. Dr. Ramaiah is with HonorHealth Vascular Group and Pulse Cardiovascular Institute in Scottsdale, Arizona.

“The overall improvement in the patients treated in the FastWave FIH study is really encouraging and provides compelling evidence supporting the feasibility and safety of the FastWave IVL system for further evaluation in a larger patient population in the United States,” commented Dr. Montero-Baker in the company’s press release.

Dr. Ramaiah added, “I am impressed by the performance of the FastWave peripheral IVL catheter—it’s both highly deliverable and easy to use. Achieving a 94% mean residual diameter stenosis reduction at the end of the procedure is equally impressive and the 30-day follow-up results reinforce the initial procedure’s success.”

FastWave’s peripheral IVL platform is designed to fracture calcium deposits using a low-profile, rupture-resistant balloon that generates circumferential ultrasonic pressure. On May 16, the company advised that it was issued its fifth patent for the technology by the United States Patent and Trademark Office.