Corvention’s KardiaPSI Balloon Catheter Introduced in Limited Launch After FDA Clearance

June 24, 2026—Corvention announced the completion of the first case performed in the United States using the company’s KardiaPSI balloon catheter. The procedure was performed by interventional cardiologist Alan Zajarias, MD, at WashU Medicine in St. Louis, Missouri.

The company advised that the successful case marks the start of the limited commercial launch of the KardiaPSI in the United States. During the limited launch phase, KardiaPSI aims to establish clinical support, precise case execution, and procedural collaboration with early adopting institutions.

In May 2026, Corvention announced FDA 510(k) clearance of the KardiaPSI platform for balloon valvuloplasty.

According to the company, the KardiaPSI balloon catheter is engineered to deliver excellent performance with enhanced control and reliability during demanding valvuloplasty procedures.

“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,” commented Dr. Zajarias in Corvention’s press release. “The device performed exactly as anticipated, remaining very stable in place, with fast inflation/deflation times, that are critical in these complex anatomical environments.”