FastWave Medical, a pioneering intravascular lithotripsy (IVL) startup, today announced the successful completion of initial first-in-human (FIH) procedures in its feasibility study of Sola ™, a next-generation coronary laser IVL (L-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.
“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, FL. “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 (E-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,” said Tristan Tieso, Chief Operating Officer at FastWave Medical. “Early feedback from these cases shows we’re on the right path.”
“Our team set out to reimagine what’s possible with coronary IVL,” added Sukanya Iyer, FastWave Medical’s Head of Technology. “Seeing Sola™ perform in human cases reinforces our commitment to give clinicians cutting-edge tools for their high-risk patients.”
Findings from this study will help shape FastWave’s regulatory submissions and the design of its U.S. pivotal trial — a key step toward broader FDA approval.
