Corvention, an emerging leader in structural heart innovations, today announced the successful completion of the first case performed in the United States utilizing its proprietary KardiaPSI™ balloon catheter. The milestone procedure was performed by world-renowned interventional cardiologist Alan Zajarias, MD, in St. Louis, Missouri.
The successful case marks the official start of KardiaPSI’s U.S. limited commercial launch, following the platform’s recent FDA 510(k) clearance for balloon valvuloplasty.
“We are thrilled to achieve this pivotal milestone alongside Dr. Zajarias and his exceptional team in St. Louis” said Michael Franklin, CEO of Corvention. “The successful clinical debut of the KardiaPSI balloon catheter underscores our commitment to providing interventionalists with advanced, high-performance tools designed to optimize outcomes in structural heart procedures. This first case lays the foundation for our controlled rollout across elite cardiovascular centers nationwide.”
The KardiaPSI balloon catheter is engineered to deliver exceptional performance, offering clinicians enhanced control and reliability during demanding valvuloplasty procedures. By initiating a limited launch phase, KardiaPSI aims to ensure unparalleled clinical support, precise case execution, and deep procedural collaboration with early adopting institutions.
“Being the first center in the United States to utilize the KardiaPSI technology is a testament to our program’s dedication to clinical excellence and cutting-edge care,” said Dr. Alan Zajarias. “The device performed exactly as anticipated, remaining very stable in place, with fast inflation/deflation times, that are critical in these complex anatomical environments.”
Cardiovascular centers interested in securing early access or being prioritized for evaluation during the ongoing limited launch period are encouraged to contact the Corvention team directly at info@corvention.com to discuss site readiness and scheduling.