The procedure, performed by Dr. Alan Zajarias in St. Louis, marked the official start of a limited rollout for the balloon catheter. Flagstaff, Arizona-based Corvention won FDA clearance for the device in balloon aortic valvuloplasty (BAV) in May.
Corvention says KardiaPSI provides interventionalists with an ultra-high-pressure solution for the precise dilation of stenotic aortic valves. It designed KardiaPSI to address the mechanical challenges of calcified valve anatomy. The device delivers high-pressure dilation with controlled expansion and a short footprint for more predictability and accuracy during valvuloplasty procedures.
The company said its catheter features fiber-reinforced materials to maintain its profile and integrity under extreme pressures. Its precision sizing allows physicians to “dial up” treatment millimeter by millimeter. This optimizes anatomical fit while minimizing interaction with unwanted structures. The device also offers fast inflation and deflation using a single syringe/inflation device for procedural efficiency.
Corvention said a limited launch allows it to ensure strong clinical support, precise case execution and deep procedural collaboration with early adopting institutions.
Commentary from Corvention officials and doctors using KardiaPSI
Michael Franklin, CEO of Corvention, said:
“We are thrilled to achieve this pivotal milestone alongside Dr. Zajarias and his exceptional team in St. Louis. 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.”
Dr. Alan Zajarias said:
“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. The device performed exactly as anticipated, remaining very stable in place, with fast inflation/deflation times, that are critical in these complex anatomical environments.”
