Corvention Announces FDA Clearance of KardiaPSI™ Ultra-High-Pressure Non-Compliant Balloon Catheter for TAVR and BAV Procedures

KardiaPSI is designed with a proprietary combination of multi-layer polymers and reinforcing fibers, arranged to provide extremely high non-compliant strength while maintaining a slim delivery profile.

The Unique Design of KardiaPSI Brings Advantages

• Ultra-high pressure performance:Carefully designed to maintain shape and integrity under the extreme pressure required to disrupt severe calcification (24 atm RBP).

• Precision Dimensions:Designed to allow doctors to "adjust" treatment millimeter by millimeter, optimizing anatomical fit while minimizing interaction with unwanted structures, with a working length of 2.5 centimeters.

• Operational Efficiency:Rapid inflation/deflation using a single syringe/inflation device.

The "Good Partner" of TAVR: Non-compliant Balloon

Against the backdrop of the rapid development of TAVR, balloon preparation has clear clinical value.

"Structural Bottleneck" of Traditional Balloons in Calcified Valves

Severely calcified aortic valves present extremely demanding mechanical challenges for balloon expansion:

• Requires extremely high expansion pressure to "tear" dense calcified nodules;

• Require the balloon to maintain shape stability under extreme pressure;

• Precise force control is required, as vascular ring tearing is one of the most dangerous complications of this surgical procedure.

KardiaPSI precisely breaks through these three mechanical bottlenecks one by one. Its 24ATM ultra-high pressure capability, fiber-reinforced structural stability, and short working length force-focusing design constitute a complete solution in principle.

• Edward Life Sciences' Ascendra BalloonCatheters have long occupied a benchmark position. The product received FDA 510(k) clearance in October 2014 and is primarily used for pre-dilation of stenotic native aortic valves prior to TAVR procedures. Ascendra, as a complementary tool for Edwards’ SAPIEN series of TAVR valves, has accumulated a strong clinical usage base and physician preference through its comprehensive structural heart disease solution bundle.

• Medtronic's Fortrex High-Pressure PTA BalloonMainly used for peripheral artery disease, and its product page does not list it as an indication for BAV.

• Boston Scientific's Athletis Ultra High-Pressure Balloon(Maximum 40 ATM) Although the pressure parameters are excellent, it is also mainly aimed at peripheral and coronary calcified lesions, and its product description does not clearly specify BAV indications.

• Corvention's KardiaPSIThe ultra-high pressure of 24ATM can effectively tear calcified nodules, but it may also increase the risk of severe complications such as aortic valve annulus tears, aortic dissection, and annular rupture leading to acute cardiac tamponade.