FastWave Medical Presents First-in-Human and Pre-Clinical Data for Coronary Laser IVL System 

Oct. 29, 2025 — FastWave Medical presented new first-in-human (FIH) and pre-clinical data for its Sola coronary laser intravascular lithotripsy (L-IVL) system at TCT 2025 (Transcatheter Cardiovascular Therapeutics) in San Francisco.

The company's FIH results were selected as a Featured Innovation, demonstrating the safety, efficacy, and procedural success of its next-generation L-IVL system in patients with complex calcified coronary lesions. FastWave also presented a Scientific Abstract, supported by pre-clinical bench and ex vivo studies, which evaluated how laser energy parameters influence sonic pressure and calcium modification — helping define the optimal dosing algorithm used in the FIH clinical feasibility study.

The results mark a key milestone in the development of FastWave's Sola L-IVL platform, underscoring the safety and procedural success of this novel technology in patients with complex calcified lesions.

The interim, core lab-adjudicated findings from FastWave's multi-center feasibility study show that treatment of nine patients with the Sola L-IVL system met their primary safety and efficacy endpoints, demonstrating freedom from 30-day major adverse cardiac events (MACE) and procedural success, defined as successful stent delivery with less than 50% residual stenosis.

"The Sola system demonstrated consistent and effective calcium modification across a range of challenging coronary lesions," said Dr. Arthur Lee, Director of Vascular Services at The Cardiac & Vascular Institute (TCAVI) and consultant to FastWave Medical. "These early results show the potential for FastWave's laser-based IVL to deliver precise, controllable energy while maintaining the safety and simplicity physicians value in existing IVL platforms."

FastWave's translational research examined how variations in sonic pressure magnitude and pulse count influence calcium modification in surrogate and excised calcified vessels in comparison to first-generation IVL technology. Micro-CT imaging confirmed uniform 360-degree energy delivery from the Sola system's actuating, single-emitter design and validated the dosing algorithm used in FastWave's FIH study.

The pre-clinical results are expected to be published in a TCT 2025 supplement of the Journal of the American College of Cardiology (JACC). Detailed findings and full presentations for the Featured Innovation and Scientific Abstract are available online.