FastWave Medical has completed enrolment in its 30-patient coronary feasibility study and received its ninth US patent from the United States Patent and Trademark Office (USPTO)—two milestones in the advancement of the company’s proprietary Sola laser intravascular lithotripsy (L-IVL) system.
Completion of enrolment in the company’s first coronary feasibility study marks another step toward evaluating the safety and performance of Sola in patients with complex, calcified coronary artery disease, a FastWave Medical press release states. All imaging and procedural data will be independently analysed by a core laboratory to ensure unbiased assessment.
“These milestones reflect the continued momentum behind our team and technology,” said Scott Nelson, chief executive officer 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.”
“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 enrolment 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 the presentation of first-in-human and pre-clinical data for the Sola L-IVL system at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–28 October, San Francisco, USA), which highlighted the platform’s potential to enhance vessel preparation and improve outcomes in complex calcified lesions.
“From the first cases to full enrolment, Sola has shown consistent energy delivery and reliable calcium modification even in difficult anatomies,” said Arthur Lee, director of Vascular Services at The Cardiac & Vascular Institute (TCAVI, Gainesville, USA) 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.”
