Medtronic plc (MDT - Free Report) recently initiated a post-market FORWARD PRO Clinical Study to measure the performance of CoreValve Evolut PRO transcatheter aortic valve implantation (TAVI) system in regular clinical treatments.
This study will evaluate the long-term performance of the next-generation self-expanding TAVI system in patients with severe symptomatic aortic stenosis and who are at an intermediate, high or extreme risk for open heart surgery. Notably, this system has recently been approved for commercial use in Europe and the United States.
Per management, this multi-center study will enroll 600 patients across 35 sites in Europe. Moreover, the study involves measuring the safety standards of CoreValve Evolut PRO valves by analyzing the all-cause mortality and all stroke rates at 30 days along with clinical performance covering valve hemodynamics and paravalvular regurgitation. Moreover per the company, patients will be continued to be followed and evaluated out to five years.
We encouragingly note that, in March 2017, the CoreValve Evolut PRO system had received FDA approval for use on symptomatic patients who are at high or extreme risk for open heart surgery. Moreover, this self-expanding TAVI system has been granted regulatory approval in Europe as well. Thus, we believe a clinical study data displaying the efficiency of the product will help the company gain traction in the Coronary & Structural Heart (CSH) space.
Interestingly, Medtronic’s CSH revenues were up 7% (8% at constant exchange rate) to $817 million on the back of high 30s constant currency growth in transcatheter aortic valves as a result of strong customer uptake of the CoreValve Evolut PRO platform in the United States and continued demand for the CoreValve Evolut R 34mm valve in the United States as well as Europe.
Notably, per a report by Medgadget, the global heart valve repair and replacement market is expected to grow from $2,281.2 million in 2014 to $3,767.0 million in 2020, at a CAGR of 8.7%.
We believe that unhealthy lifestyle and a rise in ageing population will continue to result in high incidence of cardiovascular diseases. This is further supported by data provided by GBI Research. Per the report, the global cardiovascular diseases market will see a CAGR of 4.1% by 2019, and within this space, the U.S. market is expected to witness the highest momentum at a CAGR of 4.7%.
Medtronic is based in a highly fragmented heart valve repair and replacement market. However, the market is dominated by some well-established players like Abbott (ABT - Free Report) , Boston Scientific Corporation (BSX - Free Report) and Edwards Lifesciences Corporation (EW - Free Report) , among others. Boston Scientific’s LOTUS Valve platform and Edwards Lifesciences’ SAPIEN XT SAPIEN 3 offerings are worth a mention here.
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