The FDA has granted breakthrough device designation to the pericardial transcatheter aortic valve replacement (TAVR) device developed by JenaValve Technologies.

TAVR is a minimally invasive technique during which a patient’s aortic valve is replaced by a device, without open heart surgery. TAVR has been hugely gaining in popularity in recent years due to its many advantages over the open surgical alternative (surgical aortic valve replacement, or SAVR), which include shorter hospital stays and fewer post-surgical complications. The current market for TAVR devices is largely dominated by two companies: Edwards Lifesciences (with its Sapien line of valves), and Medtronic (with its CoreValve brand). These devices are the only two valves currently approved by the FDA for use in patients with severe aortic stenosis at low risk for SAVR, giving Edwards and Medtronic a huge competitive advantage over developers of other commercially available valves.

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JenaValve’s pericardial TAVR system is the next-generation version of its original, CE-marked JenaValve porcine root system. Although this device is currently only meant for investigational use since it is not yet approved by the FDA or CE-marked, it boasts a major advantage over other commercially available devices: it is designed to treat both aortic stenosis and aortic regurgitation, while every other TAVR device is only approved to treat aortic stenosis. GlobalData estimates that approximately 1.9 million people in the US alone suffered from aortic regurgitation in 2019, opening up a much larger potential patient population for the JenaValve device compared to that for other TAVR devices.

Currently, aortic regurgitation is typically treated with open surgery. To convince physicians to instead treat their patients with aortic regurgitation using TAVR and the JenaValve device, JenaValve Technologies must robustly prove the safety and efficacy of its device through rigorous clinical trial testing. By designating JenaValve’s pericardial TAVR system as a breakthrough device, the FDA has enabled JenaValve to complete this step more easily by providing the company with priority review and communicating with it regularly to assist with device development and clinical trial protocols.

GlobalData predicts that completion of clinical trials and FDA approval of JenaValve’s pericardial TAVR system will boost the TAVR market by expanding its treatable patient population substantially. At this point, JenaValve will also gain share in the TAVR market, since it would be making the only device suitable for treatment of aortic regurgitation.