FDA clears high-pressure balloon catheter for BAV procedures
Corvention, an Arizona-based medtech startup, has received U.S. Food and Drug Administration (FDA) clearance for a new balloon catheter that clinicians use during balloon aortic valvuloplasty (BAV) procedures.
The KardiaPSI Balloon Catheter—PSI stands for precision, speed and innovation—was built to withstand the extreme pressures associated with treating severely calcified heart valves. It maintains its engineered diameter even at high pressures so focal force is delivered exactly where intended and not beyond. Balloons come in diameters 19-29 mm, in 1 mm intervals for very precise size matching to the anatomic need.
“The KardiaPSI Balloon Catheter was developed to solve a fundamental problem in valvuloplasty: the inability to consistently and reliably deliver sufficient force with precise control in calcified anatomy,” Michael Franklin, CEO and co-founder of Corvention, said in a statement. “With ultra high-pressure capability and a short, stable working profile, KardiaPSI is designed to provide a level of predictability not achievable with conventional balloons. FDA clearance allows us to bring this capability into clinical practice, equipping physicians with reliable, high-performance tools that expand what is possible in complex cases."
As the device enters commercialization, he said the device will have a high-touch rollout so the company can be responsible stewards in the clinical spaces its serves.
“We needed a short, powerful and controlled BAV option, and the KardiaPSI technology is designed to meet that challenge head-on,” added Scott Lim, MD, a veteran cardiologist, director of the Advanced Cardiac Valve Center at the University of Virginia, and member of Corvention’s advisory board. “This clearance allows us to begin the transition toward making this technology a standard component of the structural heart interventional toolkit.”
Corvention was founded in October 2021. This represents the company’s first FDA clearance, though it says it is “just getting started.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.