FastWave Medical Announces Successful First-in-Human Procedures in Study of Novel Peripheral Intravascular Lithotripsy System

 // News

January 17  

FastWave Medical completes enrollment for the first-in-human study of its innovative peripheral intravascular lithotripsy system, marking a significant milestone for the fast-moving company.

MINNEAPOLIS, Minn., Jan. 17, 2024 /PRNewswire-PRWeb/ — FastWave Medical, a pioneering medical device company focused on differentiated approaches to addressing calcified cardiovascular disease through advanced intravascular lithotripsy (IVL) technology, is pleased to announce the successful completion of enrollment for its first-in-human (FIH) study with the company’s innovative peripheral IVL technology.

The prospective, single-arm study aims to assess 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. Principal investigators Dr. Miguel Montero-Baker from Houston Methodist Hospital and HOPE Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah from HonorHealth Vascular Group and Pulse Cardiovascular Institute, conducted the procedures successfully in collaboration with the hosting investigator, Dr. Antonio Muñoa.

Dr. Montero-Baker expressed his enthusiasm, stating, “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.”

FastWave’s IVL platform is designed to treat calcific artery disease by fracturing calcium deposits using a balloon catheter that delivers shock waves. The company’s peripheral IVL technology offers a user-friendly design with a highly deliverable, low-profile, rupture-resistant balloon that generates durable and predictable circumferential ultrasonic pressure.

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

“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,” said Scott Nelson, co-founder and Chief Executive Officer of FastWave Medical. “I would like to congratulate Drs. Montero-Baker, Ramaiah, and Muñoa for their outstanding support, and acknowledge the commitment of the entire FastWave team to achieve this milestone in such a short amount of time. It’s a true honor to work alongside such a talented group.”

About FastWave Medical

FastWave Medical is at the forefront of developing intravascular lithotripsy systems for calcific artery disease. With an emphasis on procedural efficiency and cost-effectiveness, FastWave aspires to redefine the sector by introducing next-generation IVL technologies that elevate patient care and the clinician experience. For more insights, please visit

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