FastWave Medical successfully completed enrollment in its 30-patient coronary feasibility study and received its ninth U.S. patent from the United States Patent and Trademark Office (USPTO) — two major milestones in the advancement of the company’s proprietary Sola™ laser intravascular lithotripsy (L-IVL) system.
Completion of enrollment in the company’s first coronary feasibility study marks another key step toward evaluating the safety and performance of Sola™ in patients with complex, calcified coronary artery disease. All imaging and procedural data will be independently analyzed by a core laboratory to ensure unbiased assessment.
Together with the newly issued patent, these advancements strengthen FastWave’s intellectual-property portfolio and reflect continued progress in both engineering innovation and clinical development.
“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.”
Coronary artery disease (CAD) remains a leading cause of death around the world. In the United States, CAD claims more than 370,000 lives each year — about one in every five heart disease deaths — according to the CDC. Globally, cardiovascular diseases take an estimated 17.9 million lives annually. Published data indicate that approximately one-third of CAD patients have hardened, calcified plaque that makes arteries rigid and difficult to treat. These blockages resist expansion, limit stent delivery, and reduce procedural success, leaving physicians with few effective treatment options.
“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.”
These developments follow FastWave’s recent presentation of first-in-human and pre-clinical data for the Sola™ L-IVL system at TCT 2025 (Transcatheter Cardiovascular Therapeutics), which highlighted the platform’s potential to enhance vessel preparation and improve outcomes in complex calcified lesions.
“From the first cases to full enrollment, Sola™ has shown consistent energy delivery and reliable calcium modification even in difficult anatomies,” said Dr. Arthur Lee, Director of Vascular Services at The Cardiac & Vascular Institute (TCAVI) and a participating investigator in the study. “It’s rewarding to see the pre-clinical work translate into a highly performant laser-based IVL platform that shows promise of meaningfully expanding our options for treating complex coronary disease.”
FastWave continues to advance toward larger-scale clinical trials to further evaluate its next-generation IVL system.
