FastWave Medical reports first-in-human findings for Sola laser IVL system

FastWave Medical today announced new first-in-human and pre-clinical data for its Sola coronary laser intravascular lithotripsy (L-IVL) system.

Minneapolis-based FastWave designed Sola 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.

FastWave received the go-ahead to conduct the trial earlier this year. In June, it announced the first-in-human use of Sola in the study.

The company shared the findings from this study at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. FastWave’s study evaluated Sola in patients with complex calcified coronary lesions. The first-in-human results demonstrated the safety, efficacy and procedural success of the next-generation system.

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