ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.
Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.
Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at intermediate and high risk for death and complications associated with surgery.
The results, both from trials exploring use of TAVR devices in low-risk patients, earned a standing ovation for presenters at the conference, according to a Medscape report.
In the Medtronic-sponsored Evolut Low Risk study, researchers reported that the use of its self-expanding TAVR system, when compared to open-heart surgery for valve replacements, had a similar rate of disabling stroke or death from any cause at two years at 5.3% versus 6.7%, respectively.
“We now have a minimally invasive procedure that is as good as or better than surgery, while at the same time allowing most patients to be out of the hospital within a few days and be back to their normal activities within a week, and that’s pretty important,” study senior author Dr. Michael Reardon of Houston Meth...
Source: Mass Device - Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news
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