FastWave Medical reports first-in-human coronary laser IVL procedures
FastWave Medical has announced the successful completion of its initial first-in-human (FIH) procedures using a novel coronary laser intravascular lithotripsy (IVL) system in the Sola feasibility study.
Sola is a rupture-resistant balloon catheter used to breakup hardened calcium in coronary arteries using laser energy to deliver 360-degree pressure with each pulse. The company said this technology was designed to address key limitations it saw in current calcium-modification devices by improving deliverability, energy output and usability. For example, extra procedural steps were eliminated for the sake of maintaining simplicity.
The multi-center study will assess Sola's safety and performance in patients with calcified coronary artery disease.
"There's a moment in every FIH study where you see if the technology lives up to its promise," Arthur Lee, MD, director of peripheral vascular services at The Cardiac and Vascular Institute in Gainesville, Florida, said in a statement. "With Sola, we saw that moment early on. It demonstrated exceptional crossability through complex anatomy where existing IVL technology might struggle, and its 5 Hz pulse rate allowed us to deliver therapy efficiently – reducing ischemic time in patients with compromised cardiac output."
"Every step of developing Sola has focused on solving the real-world problems physicians face in treating complex arterial disease," added Tristan Tieso, chief operating officer at FastWave Medical. "Early feedback from these cases shows we're on the right path."
FastWave plans to use data from this study to help guide its regulatory submissions as well as the design of its U.S. pivotal trial, seen as a major step toward securing U.S. Food and Drug Administration (FDA) approval.
FastWave is one of several vendors competing to offer IVL therapies that can compete with the technology developed by Shockwave Medical. IVL offers a much less traumatic option compared to high-pressure balloon angioplasty and atherectomy for breaking up calcium to expend arteries for increased blood flow or prep a vessel for stent placement.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]