FastWave’s Sola Coronary Laser IVL System Evaluated in FIH Feasibility Study 

October 2, 2026—FastWave Medical announced interim results from the first-in-human (FIH) feasibility study of its Sola laser intravascular lithotripsy (L-IVL) system for treating calcified coronary artery disease. The Sola system is an investigational device and is not available for sale, advised FastWave.

According to the company, the single-arm study was composed of 30 patients who were treated at two clinical sites and followed for 30 days. Treated lesions were complex, averaging 32.6 mm in length.

The results are based on investigator-reported data and remain subject to final analysis, including independent core laboratory assessment of angiographic and intravascular imaging data.

FastWave reported that stent delivery was attempted in 28 patients in whom Sola achieved 96.4% procedural success. Additionally, there were no serious adverse events related to the study device reported through 30 days. Mean diameter stenosis was 79.1% at baseline and 12.1% after completion of the procedure.

The company stated that procedural success was defined as successful stent delivery with a final residual stenosis < 50% and freedom from in-hospital major adverse cardiovascular events.

Site-reported intravascular imaging showed calcium fracture in all 30 treated lesions. Mean minimum lumen area increased 49% after IVL treatment and before stent implantation, providing evidence of calcium modification prior to stenting.

As noted in the FastWave press release, the Sola L-IVL system is designed to treat complex calcified coronary disease. The device features include a low-profile catheter with a single actuating optical emitter.

The physician-controlled translating emitter is designed to deliver energy along the length of the target lesion. The energy pulses up to 5X faster than conventional IVL with circumferential acoustic pressure generation with every pulse, stated FastWave.

Arthur Lee, MD, performed cases in the study and commented on the device in the company’s press release.

“What stood out to me with the Sola L-IVL system was its deliverability, along with the combination of control and speed,” stated Dr. Lee, who is Director of Vascular Services at The Cardiac & Vascular Institute in Gainesville, Florida. “The ability to translate the optical emitter provides a differentiated way to direct lithotripsy along the lesion, while the 5-Hz pulse rate enables rapid energy delivery. Seeing calcium fracture in every treated lesion and meaningful luminal gain before stenting is very encouraging.”

The FastWave press release further noted that in August it received FDA approval of an investigational device exemption for the United States pivotal trial of the company’s Artero electric IVL system for the treatment of peripheral artery disease.