FastWave Receives IRB Approval for Feasibility Study of Sola Laser IVL System

May 7, 2025—FastWave Medical announced it has received institutional review board (IRB) approval to commence a coronary feasibility study using the company’s Sola laser intravascular lithotripsy (L-IVL) system. The company advised that the clinical study will lead to its planned United States pivotal trial.

According to FastWave, its next-generation Sola L-IVL system features rupture-resistant balloon catheters to treat cardiovascular calcium; a laser energy source that produces actuating, circumferential sonic pressure waves with precision and consistency; and improved operator control to safely and effectively modify calcium.

“FastWave’s L-IVL system is sophisticated, yet very easy to use,” commented Amir Kaki, MD, in the company’s press release. “It holds a lot of promise for reshaping complex arterial disease treatment, enabling cardiologists to treat calcified arteries with more precision and efficiency.” Dr. Kaki is Director of Mechanical Circulatory Support and High-Risk Coronary Interventions at Henry Ford St. John Hospital in Detroit, Michigan.

In its effort for IRB approval, FastWave partnered with Clinical Accelerator, a contract research organization that specializes in facilitating the implementation of first-in-human and early feasibility studies, noted the press release.