Corvention, a structural heart medical device company based in Flagstaff, Arizona, received 510(k) clearance from the FDA for its KardiaPSI Balloon Catheter on May 11, 2026. The device is indicated for balloon aortic valvuloplasty and delivers 24 atm in a 2.5 cm working length, intended for dilation of calcified stenotic aortic valves.
Corvention developed the device on the Moonshot Flagstaff campus, working with POBA Medical, a Flagstaff company that designs and manufactures balloon catheters. The name is a piece of industry humor. POBA, short for plain old balloon angioplasty, is a term coined by Advanced Cardiovascular Systems due to how routine balloon procedures had become by the early 1980s. POBA runs a Class 8 cleanroom with ten dedicated balloon forming production lines and offers catheter sub-assembly including laser welding, split die bonding, tipping, shaft skiving, and pleating.
The first US case followed on June 24, 2026, performed by interventional cardiologist Alan Zajarias in St. Louis, Missouri, marking the start of a limited commercial launch. Corvention CEO Michael Franklin described the case as the foundation for a controlled rollout across cardiovascular centers nationwide.
Flagstaff has supported this kind of work for a while. W.L. Gore has manufactured stents and catheters there for more than three decades and employs roughly 1,600 people in the city.
