Corvention Launches KardiaPSI Balloon Catheter in the U.S. Following Successful First Case

Corvention Launches KardiaPSI Balloon Catheter in the U.S.

Corvention, an innovative player in the field of structural heart technologies, proudly announces the successful completion of its first case using the KardiaPSI balloon catheter in the United States. This groundbreaking milestone, conducted by renowned interventional cardiologist Dr. Alan Zajarias in St. Louis, Missouri, marks the beginning of a limited commercial rollout following the recent FDA 510(k) clearance that allows for balloon valvuloplasty procedures using this advanced device.

The KardiaPSI balloon catheter represents a significant advancement in interventional cardiology, designed to enhance the precision and effectiveness of valvuloplasty procedures. Michael Franklin, CEO of Corvention, expressed his excitement about this achievement, stating, "We are thrilled to reach this pivotal milestone alongside Dr. Zajarias and his exceptional team in St. Louis. The successful clinical debut of the KardiaPSI balloon catheter emphasizes our dedication to equipping interventionalists with enhanced, high-performance tools that significantly improve outcomes in structural heart procedures."

The innovative design of the KardiaPSI ensures exceptional performance, granting clinicians enhanced control and reliability during intricate procedures. The device is built for demanding environments, which is crucial when navigating the complexities of various anatomical structures within the heart. As part of its limited launch strategy, Corvention aims to provide unprecedented clinical support, assuring precise execution of cases while establishing collaboration with select cardiovascular centers across the nation.

Dr. Alan Zajarias, who performed the initial procedure, shared his insights, stating, "Being the first center in the U.S. to utilize the KardiaPSI technology is a testament to our program's dedication to clinical excellence and cutting-edge care. The device performed exactly as anticipated, demonstrating remarkable stability in placement, along with rapid inflation and deflation times that are critical in these complex anatomical settings."

Corvention encourages interested cardiovascular centers to reach out for early access during this phase of limited launch. Institutions looking to be prioritized for evaluation should contact the Corvention team to discuss their site’s readiness and scheduling.

About Corvention

Headquartered in Flagstaff, Arizona, Corvention specializes in the development of innovative medical devices aimed at enhancing structural heart interventions within modern catheterization laboratories. Founded in 2021, the company remains focused on creating precision tools that improve clinical safety, efficacy, and predictability in cardiovascular procedures. As it advances new technologies, Corvention is dedicated to shaping the future of heart health.

For media inquiries, Alejandro Froimovich, VP of Clinical Medical Affairs, can be reached at [email protected]

As Corvention embarks on this new chapter with the KardiaPSI, it stands poised to redefine the standards of care in the field of cardiology, addressing the critical needs of healthcare providers and patients alike, while reinforcing its commitment to innovation and excellence.