FastWave Completes Enrollment in Feasibility Study of Sola Laser IVL System

November 11, 2025—FastWave Medical announced the completion of enrollment in the 30-patient coronary feasibility study of the company’s Sola laser intravascular lithotripsy (L-IVL) system.

All imaging and procedural data will be independently analyzed by a core laboratory to ensure unbiased assessment, noted the company.

According to FastWave, enrollment completion marks a step toward evaluating the safety and performance of Sola in patients with complex, calcified coronary artery disease. The company advised that it continues to advance toward larger-scale clinical trials to further evaluate its next-generation IVL system.

FastWave also reported that it received its ninth patent from the United States Patent and Trademark Office related to the Sola L-IVL system.

The company recently announced that first-in-human and preclinical data demonstrated the safety, efficacy, and procedural success of the next-generation Sola coronary L-IVL system. The data, which highlighted the platform’s potential to enhance vessel preparation and improve outcomes in complex calcified lesions, were presented at the TCT 2025 scientific symposium, noted FastWave.

“From the first cases to full enrollment, Sola has shown consistent energy delivery and reliable calcium modification even in difficult anatomies,” commented Arthur Lee, MD, in FastWave’s press release. “It’s rewarding to see the preclinical work translate into a highly performant laser-based IVL platform that shows promise of meaningfully expanding our options for treating complex coronary disease.”

Dr. Lee, who serves as a participating investigator in the study, is Director of Vascular Services at The Cardiac & Vascular Institute in Gainesville, Florida.