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

FastWave Medical Reports First-in-Human Findings for Sola Laser IVL System

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

The Sola system, designed to treat cardiovascular calcium, features sleek, rupture-resistant balloon catheters and a custom laser energy source producing actuating, circumferential sonic pressure waves.

FastWave received approval to conduct the trial earlier this year and announced the first-in-human use of Sola in June, with findings presented at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

The study evaluated Sola in patients with complex calcified coronary lesions, demonstrating improved operator control to safely and effectively modify calcium.

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Author's summary: FastWave Medical shares first-in-human findings for Sola laser IVL system.

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MassDevice MassDevice — 2025-10-29