BREAKING: FDA approves TAVR valves for low-risk patients

The FDA today expanded the approval for replacement heart valves made by Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) to include patients at low risk from open heart surgery.

The expanded transcatheter aortic valve replacement approvals, for Medtronic’s CoreValve Evolut R and CoreValve Evolut Pro and Edwards’s Sapien 3 and Sapien 3 Ultra devices, widens the potential patient pool for the valves beyond previously approved intermediate- and high-risk patients.

“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,” Cardiovascular Devices Office director Dr. Bram Zuckerman said. “As the FDA assesses new medical technologies or expanded uses for previously approved products such as these, the agency remains committed to evaluating evidence from clinical trials and real-world clinical data in both the premarket and postmarket settings to ensure patients have access to high-quality, safe, and effective medical devices.”

Medtronic said the FDA based the expanded approval on its 1,400-patient Evolut Low Risk trial involving its CoreValve, Evolut R and Evolut Pro valves.

“The majority of my patients want a replacement valve that’s going to minimize the risk of death, stroke and other cardiovascular events during the procedure and allow them to leave the hospital faster and recover sooner. In patients appropriate for a biologic valve, that option is going to be TAVR,” principal investigator and senior author Dr. Michael Reardon, of the Houston Methodist DeBakey Heart & Vascular Center, said in prepared remarks. “With the low-risk approval, risk stratification for TAVR treatment is becoming obsolete and heart teams will likely need to assess treatment options based on anatomical characteristics, concomitant risk factors and also patient preference.”

“Low-risk patients were younger and healthier than those patients enrolled in our prior studies and were better able to weigh the risks and benefits of surgery or TAVR based on their value preferences,” added co-principal investigator Dr. Jeffrey Popma of Boston’s Beth Israel Deaconess Medical Center. “It is our impression that patients will now be able to make a choice on the method of aortic valve replacement based on an informed risk-benefit discussion with their heart team.”

“This expanded indication means that physicians and patients will have more freedom to choose the right aortic valve replacement procedure based on each patient’s health and quality-of-life goals, which may vary based on their age, frailty and anticipated daily activity,” structural heart & cardiac surgery CMO Dr. Pieter Kappetein said in a press release. “This is an exciting time for patients and the clinical community alike as we now have an aortic valve replacement technology clinically demonstrated to be well-suited for the thousands of new patients who seek a less invasive treatment option that helps them get back to active living.”

The federal safety watchdog used Edwards’s Partner 3 study as the basis for the Sapien expansion, that Irvine, Calif.-based company said.

“The Partner 3 trial demonstrated that low-risk patients treated with the Sapien 3 TAVR experienced extraordinary outcomes with 1.0% rates of death or disabling stroke at one year, a short length of stay and 96% discharged to home or self-care. Sapien 3 is the only valve to achieve superiority over surgery based on the pre-specified primary endpoint,” national co-principal investigator Dr. Martin Leon, of the NewYork-Presbyterian/Columbia University Medical Center, said in an emailed press release. “Today’s FDA approval of Sapien 3 TAVR will expand access to this proven therapy, which should be considered the preferred treatment for the majority of low-risk severe AS patients.”

“Severe AS is a debilitating disease that often goes undiagnosed and is under-treated,” added TAVR vice president Larry Wood. “This approval is a significant milestone and will allow all patients diagnosed with severe AS to be considered for TAVR based on their individual preferences and anatomical considerations versus traditional risk scoring.”

The news sent EW shares up 2.3% to $220.13 apiece today in late-morning trading; MDT shares were up 1.2% to $102.94 each.