FastWave Medical has announced the successful completion of enrolment for its first-in-human (FIH) study with the company’s peripheral intravascular lithotripsy (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 Miguel Montero-Baker from Houston Methodist Hospital and HOPE Vascular & Podiatry Clinic and Venkatesh Ramaiah from HonorHealth Vascular Group and Pulse Cardiovascular Institute, conducted the procedures successfully in collaboration with the hosting investigator, Antonio Muñoa.
Montero-Baker stated: “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 shockwaves. 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, the company says in a press release.
“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 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 enrolment 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 honour to work alongside such a talented group.”
