Flagstaff, AZ (May 11, 2026) – 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 an ultrahigh-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 FDA clearance of the KardiaPSI™ system represents a vital step forward in our mission to refine and personalize structural heart interventions,” said Michael Franklin, CEO of Corvention. “Valvuloplasty remains a cornerstone of cardiac care, and our goal is to provide physicians with a tool that offers both the power and the precision required for complex anatomy. As we move into this next phase, we are focused on a deliberate, high-touch rollout to ensure clinical excellence and optimal 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. Further updates regarding commercial availability will be provided as the rollout progresses.
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.
About Corvention
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.
Media Contact
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