FastWave’s Sola Coronary Laser IVL System Evaluated in FIH and Preclinical Data

October 29, 2025—FastWave Medical announced that new first-in-human (FIH) and preclinical data demonstrated safety, efficacy, and procedural success of its next-generation Sola coronary laser intravascular lithotripsy (L-IVL) system to treat patients with complex calcified coronary lesions.

The FIH results were presented as a Featured Innovation at the TCT 2025 scientific symposium.

According to Fast Wave, the interim, core lab-adjudicated findings from its multicenter feasibility study showed that treatment of nine patients with the Sola L-IVL system met their primary safety and efficacy endpoints with freedom from 30-day major adverse cardiac events (MACE) and procedural success (defined as successful stent delivery with < 50% residual stenosis).

“The Sola system demonstrated consistent and effective calcium modification across a range of challenging coronary lesions,” commented Arthur Lee, MD, in the company’s press release.

Dr. Lee, who is Director of Vascular Services at The Cardiac & Vascular Institute in Gainesville, Florida, continued, “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 also reported the TCT presentation of a Scientific Abstract, which supported by preclinical bench and ex vivo studies, evaluated how laser energy parameters influence sonic pressure and calcium modification to help define the optimal dosing algorithm used in the FIH clinical feasibility study.

FastWave further reported that its 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 360º energy delivery from the Sola system’s actuating, single-emitter design and validated the dosing algorithm used in FastWave’s FIH study, noted the company.

The company advised that the preclinical results (TCT-168) by Dr. Lee et al were published in the TCT 2025 supplement of the Journal of the American College of Cardiology. Additionally, the TCT presentations are available online. The Featured Innovation is titled “Procedural success and imaging outcomes from the FastWave FIH experience”) and the Scientific Abstract is titled “Role of sonic pressure and energy optimization.”