FastWave Medical Begins Study of its Coronary Laser IVL System

Intravascular lithotripsy (IVL) startup FastWave Medical has successfully completed the initial first-in-human (FIH) procedures in its feasibility study of Sola, a next-generation coronary laser IVL system. The multi-center study will assess Sola’s safety and performance in patients with calcified coronary artery disease.

Sola is a rupture-resistant balloon catheter designed to help physicians treat hardened calcium in blood vessels with precision and control. Its laser energy delivers 360-degree pressure with each pulse, making therapy consistent and effective, even in challenging lesions, according to the company.

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

This milestone follows FastWave’s successful FIH study of Artero, its peripheral electric IVL system, which demonstrated 100% procedural success and no adverse events at 30-day follow-up.

“Every step of developing Sola has focused on solving the real-world problems physicians face in treating complex arterial disease,” FastWave Medical Chief Operating Officer Tristan Tieso stated. “Early feedback from these cases shows we’re on the right path.” 

Findings from this feasibility study will help shape FastWave’s regulatory submissions and the design of its U.S. pivotal trial, a key step toward U.S. Food and Drug Administation approval. 

“Our team set out to reimagine what’s possible with coronary IVL,” FastWave Medical Head of Technology Sukanya Iyer commented. “Seeing Sola perform in human cases reinforces our commitment to give clinicians cutting-edge tools for their high-risk patients.”

FastWave Medical pioneers next-generation intravascular lithotripsy (IVL) technology to transform the treatment of calcific artery disease in peripheral and coronary applications. Founded by industry veterans with deep startup and multinational medical device experience, FastWave has secured more than $40 million in venture funding to advance its dual-platform IVL systems. The company’s technologies address key limitations in current calcium-modification devices by improving deliverability, energy output, and usability, eliminating extra procedural steps while maintaining the simplicity that has driven IVL’s rapid clinical adoption.