FastWave Medical has announced the successful completion of initial first-in-human (FIH) procedures in its feasibility study of Sola, the coronary laser intravascular lithotripsy (IVL) system.
The multicentre 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 Arthur Lee, director of Peripheral Vascular Services at The Cardiac and Vascular Institute (TCAVI), in Gainesville, USA. “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 ischaemic time in patients with compromised cardiac output.”
In a recent press release the company has highlighted that this milestone follows FastWave’s 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,” he said.
“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.”
The company state that findings from this study will help shape FastWave’s regulatory submissions and the design of its US pivotal trial, a key step toward broader US Food and Drug Administration (FDA) approval.
