The transcatheter aortic valve replacement market received one of the biggest jolts of the year when FDA expanded indications of both Edwards Lifesciences and Medtronic’s valves.
FDA’s measure would open up the valves to be used in younger and low-risk patients. The agency said these transcatheter valves – Edwards’ Sapien 3, and Sapien 3 Ultra, with Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery.
“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in FDA’s Center for Devices and Radiological Health.
In a clinical study to evaluate safety and effectiveness, 503 patients with severe aortic stenosis at low-risk for surgical complications were randomly selected to have aortic valve replacement with Irvine, CA-based Edwards' Sapien 3 transcatheter heart valve, and 497 were randomly selected to have aortic valve replacement with traditional open-heart surgery using an approved surgical tissue valve.
In a separate study, 734 low-risk patients with severe aortic stenosis were randomly selected to have aortic valve replacement with Dublin-based Medtronic’s CoreValve Evolut R or CoreValve Evolut PRO transcatheter valve, and 734 were randomly selected to have aortic valve replacement with traditional open-heart surgery using an approved surgical tissue valve.
At an average of 15 to 17 months follow-up, when outcomes (such as all-cause mortality or stroke) for transcatheter and surgical patients were compared, the transcatheter heart valve achieved comparable results to surgery, demonstrating a reasonable assurance of safety and effectiveness of the transcatheter heart valves in low surgical risk patients.
Jason Mills, an analyst with Canaccord Genuity said the low-risk patient population could boost the TAVR market.
We think these low-risk data sets could accelerate TAVR utilization, as low risk patients represent the largest portion of the severe symptomatic aortic stenosis patient population,” Mills wrote in research notes. “With surgical risk stratification now effectively eliminated from the TAVR/SAVR decision-making process, we think over time the conversation around treatment strategy will shift toward TAVR relatively quickly, such that the narrative evolves to “in which patient is TAVR not the preferred choice,” implying in most cases – ssAS patients as young as 65-years-old and up – TAVR will be the preferred treatment.”
At this point, it could probably be argued that 2019 will go down in history as one of the most influential years in the history of TAVR.
With this new indication to treat young patients, along with FDA giving approval for Boston Scientific’s Lotus Edge in the U.S. and Edwards discontinuing work on the Centera TAVR system, it looks like 2019 might be a defining year for the market.