The Minneapolis-based company also received its ninth patent from the U.S. Patent and Trademark Office (USPTO). With the completed enrollment, the milestones mark major advancements for the company’s proprietary Sola system.
FastWave designed the Sola laser intravascular lithotripsy (L-IVL) system to treat cardiovascular calcium with sleek, rupture-resistant balloon catheters. Its custom laser energy source produces actuating, circumferential sonic pressure waves. Sola enables improved operator control to safely and effectively modify calcium.
The company received the go-ahead to conduct a trial earlier this year. In June, it announced the first-in-human use of Sola in the study. Last month, the company shared new first-in-human and pre-clinical data for Sola at TCT 2025.
The IVL space continues to heat up with Johnson & Johnson acquiring Shockwave Medical, a leader in IVL, for $13 billion last year.
Other companies, such as AVS, Elixir Medical and Vantis Vascular are making waves in IVL, too. Boston Scientific recently joined the fray with its acquisition of Bolt Medical, too. Abbott is making its own IVL play, too, advancing its own system.
FastWave says completing enrollment marks another key step toward evaluating Sola’s safety and performance. It says its advancements strengthen its IP portfolio and reflect continued progress in both engineering innovation and clinical development.
The company hopes to continue moving toward larger scale clinical trials to further evaluate the next-generation IVL system.
Commentary from FastWave Medical officials and study investigators
Scott Nelson, CEO of FastWave Medical, said:
”These milestones reflect the continued momentum behind our team and technology. 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.”
Trent Mengel, head of clinical at FastWave Medical
“We are just beginning to see what’s possible with coronary IVL, and it’s incredibly exciting. 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.”
Dr. Arthur Lee, director of vascular services at The Cardiac & Vascular Institute (TCAVI) and a participating investigator in the study, said:
“From the first cases to full enrollment, Sola™ has shown consistent energy delivery and reliable calcium modification even in difficult anatomies. 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.”
