FastWave Finishes Enrollment in Laser IVL Feasibility Study, Gains 9th Patent

FastWave Medical has completed enrollment in its 30-patient coronary feasibility study and earned its ninth U.S. patent from the United States Patent and Trademark Office (USPTO). These are two major milestones to advance the company’s Sola laser intravascular lithotripsy (L-IVL) system.

The feasibility study will evaluate Sola’s safety and performance in patients with complex, calcified coronary artery disease (CAD). Imaging and procedural data will be independently assessed by a core laboratory for unbiased evaluation.

“These milestones reflect the continued momentum behind our team and technology,” said Scott Nelson, CEO of FastWave Medical. “Each step brings us closer to delivering the next generation of IVL systems designed to meet the real-world challenges physicians face when treating complex cardiovascular disease.”

Data shows that about one-third of CAD patients have hardened, calcified plaque that makes arteries rigid and tough to treat. These blockages resist expansion, limit delivery of stents, and reduce procedural success.

“We are just beginning to see what’s possible with coronary IVL, and it’s incredibly exciting,” added Trent Mengel, head of clinical at FastWave Medical. “Completing enrollment in this study demonstrates the dedication of our clinical partners and the growing confidence in laser-based IVL as the next evolution of calcium modification therapy.”

This news follows the company’s recent reveal of first-in-human and preclinical data for the Sola L-IVL system at TCT 2025, which demonstrated the platform’s potential to enhance vessel preparation and improve outcomes in complex calcified lesions.