FastWave Medical announced today that it received Institutional Review Board (IRB) approval to begin a coronary feasibility study.
The study utilizes Sola, the company’s novel laser intravascular lithotripsy (IVL) system. FastWave partnered with Clinical Accelerator to secure the approval, which paves the way for its planned U.S. pivotal trial.
Minnapolis-based FastWave designed Sola to treat cardiovascular calcium with sleek, rupture-resistant balloon catheters. Its custom laser energy source produces actuating, circumferential sonic pressure waves. Sola enables improved operator control to safely and effectively modify calcium.
The Sola platform offers durable and fast energy delivery with enhanced sonic output. It helps to navigate complex arterial anatomy through a high-performing catheter. IVL remains a hot space, especially with Johnson & Johnson’s $13.3 billion acquisition of Shockwave Medical followed by Boston Scientific’s market entry with the Bolt IVL system and Abbott’s IVL play with an FDA investigational device exemption nod.
The FastWave technology was used in a first-in-human study last year, with the company reporting positive results in May 2024. In December 2024, the company announced another patent for its laser IVL technology.
In addition to the coronary feasibility study, FastWave plans to commence an IDE study this year. It plans to evaluate its Artero electric IVL system in the treatment of peripheral artery disease (PAD).
“Our committed team is aiming to set a new standard in the IVL category, enabling physicians to achieve best-in-class clinical outcomes. This IRB approval represents a major milestone in our mission to deliver transformative technology to physicians and their patients,” said Scott Nelson, co-founder and CEO of FastWave.
