FastWave Reveals First-in-Human Data for Sola Laser IVL System

FastWave Medical presented new first-in-human (FIH) and preclinical data for its Sola coronary laser intravascular lithotripsy (L-IVL) system at this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference.

The FIH results showed the safety, efficacy, and procedural success of the company’s next-gen L-IVL system to treat complex calcified coronary lesions. FastWave also presented a scientific abstract backed by preclinical bench and ex vivo studies that assessed how laser energy parameters influence sonic pressure and calcium modification—helping define the best dosing algorithm used in the FIH clinical feasibility study.

Interim, core lab-adjudicated findings from the multi-center study showed treating nine patients with the Sola L-IVL system met safety and efficacy endpoints, showing freedom from 30-day major adverse cardiac events (MACE) and procedural success. This was defined as successful stent delivery with under 50% residual stenosis.

FastWave’s translational research examined how variation in sonic pressure magnitude and pulse count affect calcium modification in surrogate and excised calcified vessels compared to first-gen IVL tech. Micro-CT imaging confirmed uniform 360-degree energy delivery from Sola’s actuating, single-emitter design and validated the dosing algorithm in the FIH study.

“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.”