FastWave Begins FIH Feasibility Study of Sola Coronary Laser IVL System

June 3, 2025—FastWave Medical announced the completion of the initial first-in-human (FIH) procedures in its feasibility study of the Sola next-generation coronary laser intravascular lithotripsy (L-IVL) system. On May 7, 2025, the company announced it received institutional review board approval to commence the feasibility study.

According to FastWave, the multicenter study will assess the Sola L-IVL system’s safety and performance in patients with calcified coronary artery disease.

Findings from the FIH feasibility study will inform FastWave’s regulatory submissions and the design of its United States pivotal trial of the Sola device, advised the company.

FastWave Medical stated that the Sola L-IVL system is a rupture-resistant balloon catheter designed to treat hardened calcium in blood vessels with precision and control. The company noted that the device’s laser energy delivers 360º pressure with each pulse, making therapy consistent and effective, even in challenging lesions.

“There’s a moment in every FIH study where you see if the technology lives up to its promise,” commented Arthur Lee, MD. “With Sola, we saw that moment early on. It demonstrated exceptional crossability through complex anatomy where existing IVL technology might struggle, and its 5-Hz pulse rate allowed us to deliver therapy efficiently, reducing ischemic time in patients with compromised cardiac output.”

Dr. Lee is Director of Peripheral Vascular Services at The Cardiac & Vascular Institute in Gainesville, Florida.