FLAGSTAFF, Ariz., May 11, 2026
Corvention announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s KardiaPSI™ Balloon Catheter, a next-generation structural heart device developed for balloon aortic valvuloplasty (BAV) procedures. The newly cleared catheter is engineered to deliver ultra high-pressure dilation up to 24 atmospheres (atm) while maintaining precise control and stability during treatment of heavily calcified stenotic aortic valves. The milestone positions Corvention among emerging innovators in the rapidly expanding structural heart intervention market and strengthens the company’s commercialization strategy for advanced cardiovascular technologies.
The KardiaPSI™ Balloon Catheter was specifically designed to address longstanding procedural challenges associated with severe calcified valve anatomy, where conventional balloon technologies may struggle to provide adequate force and predictable expansion. According to Corvention, the device combines ultra high-pressure performance, controlled expansion capabilities, and a short 2.5 cm working length, enabling interventional cardiologists to perform more precise and efficient valvuloplasty procedures in complex cardiovascular cases.
Advanced Balloon Technology Designed for Structural Heart Procedures
Balloon aortic valvuloplasty remains an important interventional procedure used to temporarily relieve obstruction caused by severe aortic valve stenosis, particularly in patients undergoing transcatheter aortic valve replacement (TAVR) preparation or those requiring palliative treatment. Corvention developed KardiaPSI™ to improve procedural precision and provide physicians with enhanced control during dilation of heavily calcified valves.
The balloon catheter utilizes fiber-reinforced materials engineered to withstand extreme inflation pressures while preserving device integrity and maintaining stable expansion characteristics. The technology allows physicians to adjust treatment sizing incrementally, optimizing anatomical fit while reducing unwanted interaction with surrounding cardiac structures. The system is also designed to improve procedural efficiency through rapid inflation and deflation using a single syringe or inflation device.
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Corvention Chief Executive Officer and Co-Founder Michael Franklin stated that the device was created to solve a major limitation in current valvuloplasty procedures: the difficulty of consistently delivering sufficient dilation force with predictable control in calcified anatomy. According to Franklin, FDA clearance now enables the company to bring the technology into clinical practice and support physicians treating increasingly complex structural heart conditions.
Structural Heart Innovation Continues Accelerating
The structural heart intervention market continues to expand globally as healthcare providers increasingly adopt minimally invasive cardiovascular procedures for treating valvular heart disease. Severe calcific aortic stenosis remains one of the most common and life-threatening cardiac conditions among aging populations, driving ongoing demand for advanced interventional tools capable of improving procedural outcomes and reducing complications.
Corvention’s Advisory Board Chair, Dr. Scott Lim, emphasized the importance of developing shorter, more controlled balloon technologies capable of handling difficult calcified anatomy. He noted that KardiaPSI™ has the potential to become an important component of the modern structural heart intervention toolkit due to its high-pressure performance and controlled dilation capabilities.
Industry analysts continue to identify structural heart technologies as one of the fastest-growing sectors within the global medical device industry, fueled by increasing procedural volumes, aging patient populations, and advancements in catheter-based cardiovascular therapies. Devices capable of improving precision, efficiency, and safety during complex heart procedures are expected to play a critical role in next-generation cardiovascular intervention strategies.
Commercial Rollout and Clinical Expansion Plans Underway
Following the FDA 510(k) clearance, Corvention confirmed that it is initiating a phased commercial rollout strategy focused on physician training, clinical support, and infrastructure development before broader national expansion. The company stated that it intends to prioritize high-touch clinical implementation to ensure successful adoption across leading structural heart centers.
Founded in 2021 and headquartered in Flagstaff, Arizona, Corvention focuses on developing specialized cardiovascular devices designed for modern catheterization laboratories. The company’s broader mission centers on improving the safety, efficacy, and predictability of structural heart interventions through precision-engineered medical technologies.
The FDA clearance of KardiaPSI™ further reinforces the accelerating pace of innovation across cardiovascular MedTech while highlighting growing demand for advanced catheter-based solutions capable of improving treatment outcomes for patients suffering from severe structural heart disease.
Source: Corvention press release
