Corvention Announces FDA 510(k) Clearance for the KardiaPSI™ Balloon Catheter

Corvention's newly FDA-cleared KardiaPSI™ Balloon Catheter delivers an ultra high-pressure 24 atm solution for structural heart interventionalists, enabling controlled, powerful and fast dilation of calcified stenotic aortic valves with its 2.5 cm working length.

FLAGSTAFF, Ariz., May 11, 2026 /PRNewswire/ -- Corvention, a structural heart medical device company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its KardiaPSI™ Balloon Catheter. The device is indicated for balloon aortic valvuloplasty (BAV), providing interventionalists with a n ultra high-pressure solution designed for the precise dilation of stenotic aortic valves.

The KardiaPSI™ platform was engineered to address the mechanical challenges of calcified valve anatomy. By delivering high-pressure dilation with controlled expansion and a short footprint, the system offers a new level of predictability and accuracy during valvuloplasty procedures.

Executive Perspectives

"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." said Michael Franklin, CEO and Co-Founder of Corvention. "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 we enter commercialization, we are committed to a disciplined, high-touch rollout and to being responsible stewards of the clinical spaces we serve, with a focus on supporting improved and durable patient outcomes."

Dr. Scott Lim, Chair of Corvention's Advisory Board, added: " We needed a short, powerful and controlled BAV option, and The KardiaPSI™ technology is designed to meet that challenge head-on. This clearance allows us to begin the transition toward making this technology a standard component of the structural heart interventional toolkit."

Commercial Readiness Update

Following this regulatory milestone, Corvention is initiating a controlled, phased market introduction. To ensure the highest standard of clinical support and physician training, the company will focus its current efforts on establishing the necessary commercial infrastructure and strategic support networks required for a successful national launch. To prioritize your center during this early rollout, please reach out to us through https://corvention.com/contact-us/

About the KardiaPSI™ Technology:

The KardiaPSI™ balloon catheter is designed with fiber-reinforced materials intended to provide:

• Ultrahigh-Pressure Performance: Engineered to maintain profile and integrity under extreme pressures required to disrupt heavy calcification (24 atm RBP).
• Precision Sizing: Designed to allow physicians to "dial up" treatment millimeter by millimeter, optimizing anatomical fit, while minimizing interaction with unwanted structures with a 2.5 cm working length.
• Procedural efficiency: Fast inflation/deflation using a single syringe/inflation device.

Based in Flagstaff, Arizona, Corvention is a medical device company dedicated to the development of specialized tools for structural heart interventions in modern-day catheterization laboratories. Founded in 2021, the company focuses on developing precision tools that enhance clinical safety, efficacy, and predictability of cardiovascular interventions.

For more information, visit us at https://www.corvention.com

Media Contact:

Alex Froimovich
[email protected]

SOURCE Corvention