Medtronic has announced the commencement of a new clinical study assessing the performance of its Intrepid transcatheter mitral valve replacement (TMVR) system.
The APOLLO trial will evaluate the safety and efficacy of the Intrepid system in up to 1,200 patients with severe, symptomatic mitral valve regurgitation, with the first patient taking part in the study having now been treated.
“Medtronic has announced the enrolment of the first patient in a new study of its Intrepid transcatheter mitral valve replacement system.“
The aim of the study will be to assess the device's impact on all-cause mortality, all-stroke, reoperation and cardiovascular hospitalisation at one year, with secondary endpoints including quality of life and valve performance in patients with severe symptomatic mitral regurgitation.
Sean Salmon, senior vice-president and president of Medtronic's coronary and structural heart division, said: "We are excited to investigate whether this technology holds promise for the large number patients suffering from the debilitating symptoms of severe mitral regurgitation."
Intrepid integrates self-expanding, dual-stent technology with a replacement tissue heart valve to facilitate catheter-based implantation. It has not yet received regulatory approval for commercial use outside of clinical studies.
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