FastWave Medical has completed the first human procedures with its Sola coronary laser intravascular lithotripsy system.
The company said that these initial procedures marked the start of its multi-center feasibility study evaluating the platform’s safety and performance.
Related: Paradromics reports first-in-human Connexus BCI procedure
The Minneapolis-area startup developed Sola as a laser-based IVL (L-IVL) balloon catheter for patients with calcified coronary artery disease. Unlike traditional IVL that uses mechanical shockwaves, Sola uses laser pulses to deliver 360-degree energy within the vessel, aiming for more consistent calcium disruption across complex anatomies.
“There’s a moment in every FIH study where you see if the technology lives up to its promise,” said Dr. Arthur Lee of TCAVI in Gainesville, Florida. “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.”
The new system follows FastWave’s earlier Artero electric IVL system that it designed for peripheral artery disease. That device completed its first-in-human study in 2024 with 100% procedural success and no adverse events reported at 30 days.
“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. “Early feedback from these cases shows we’re on the right path.”
FastWave plans to use findings from this feasibility study to inform its regulatory strategy and the design of a future U.S. pivotal trial.
