US FDA Approves First Intermediate-Risk Indication For TAVR
The expanded indication for Edwards' Sapien XT and Sapien 3 arrives about when the company had predicted.
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Market Intel: Relentless Rise Of Transcatheter Tech: Heart Valve Repair Turns Back On Open Surgery
The global market for products treating heart valve disease is expected to exceed $8bn by 2021, driven largely by the rising number of elderly patients with cardiovascular disease, obesity and growing prevalence of diabetes. This, in turn, is fueling significant innovation in minimally invasive techniques, particularly in the leading area of transcatheter aortic valve replacement (TAVR), but also in transcatheter mitral valve repair (TMVrep) systems, both of which offer patients quicker recovery times, less discomfort and greater safety compared to traditional surgical heart valve repair and replacement. This feature looks more closely at the competitive landscape and dynamics of these two fast-growing market segments, as well as gives insight into what the users – the physicians – think of these technologies.
US FDA Green-Lights Medtronic's CoreValve Evolut For Intermediate Risk
The approval, based on the results of the SURTAVI trial, comes a few months ahead of analysts' expectations and is welcome news for Medtronic in its effort to keep pace with TAVR leader Edwards in the US market.
ACC 2017: SURTAVI Supports Intermediate-Risk Intervention For Medtronic's CoreValve
In an interview with Medtech Insight, the lead investigator of SURTAVI, an ongoing trial of Medtronic's CoreValve in intermediate risk patents, says transcatheter aortic valve is continuously improving and will probably soon be indicated for even low-risk patients, but that surgical valve replacement will have an important role to play for the foreseeable future.