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FastWave Medical has successfully completed the first human procedures using its new Sola coronary laser intravascular lithotripsy (L-IVL) system, marking the start of a multi-center feasibility study. This milestone positions the Minneapolis-area startup at the forefront of innovation in treating calcified coronary artery disease—a condition that makes standard procedures like angioplasty more difficult and less effective.
Unlike traditional intravascular lithotripsy, which uses mechanical shockwaves to break down hardened calcium deposits in blood vessels, Sola uses laser-generated 360-degree energy pulses. This laser-based approach is designed to improve the precision and effectiveness of treatment, especially in complex anatomies where traditional devices often struggle. Dr. Arthur Lee, one of the first to use the device, praised its ability to efficiently navigate and treat challenging vessel structures, noting that its rapid 5Hz pulse rate helped reduce the time patients' hearts spent without oxygenated blood.
Sola follows FastWave’s earlier success with its Artero electric IVL system for peripheral artery disease, which achieved 100% procedural success and no adverse events in its first human study. According to FastWave COO Tristan Tieso, Sola is the result of continued efforts to solve the practical challenges doctors face when treating severe arterial calcification.
The current feasibility study will help shape FastWave’s next steps, including regulatory plans and the design of a pivotal U.S. trial. If successful, Sola could become a game-changing option for cardiologists dealing with difficult-to-treat coronary artery cases.
