Medtronic’s TMVR clears early clinical test as pivotal trial fires up

medtronic operational headquarters
Medtronic is one of clutch of companies aiming to challenge Abbott for the TMVR market.

Medtronic has posted a look at data on the first 50 patients treated with its transcatheter mitral valve replacement (TMVR) system. The navigation of the early test follows shortly after Medtronic treated the first patient in the pivotal trial it hopes will establish it as a player in the nascent TMVR market.

Among the first 50 patients treated with Medtronic’s self-expanding Intrepid TMVR system in the pilot study, the cardiovascular device was successfully implanted 98% of the time. That result came from the initial 30-day outcome assessment. Medtronic also saw evidence of reductions in leakage of blood backward through valves, with patients going from moderate to severe cases at baseline to trace to mild after 30 days.

Medtronic presented the data this week at the Transcatheter Cardiovascular Therapeutics Annual Meeting. The publication of the data comes weeks after Medtronic showed its satisfaction with the early performance of Intrepid by moving the device into a pivotal trial.

That study will show more conclusively how Medtronic’s Intrepid copes with the anatomically and physiologically challenging anatomy of mitral valves. And by extension, whether Medtronic can take market share from Abbott’s incumbent MitraClip and a chasing pack that includes Edwards Lifesciences. All three companies have bought their way into the emerging market in recent years in deals worth upward of $1 billion.

Abbott bought itself the leadership position for up to $410 million in 2009. That gave the company ownership of MitraClip, which went on to win approval in 2013. The years of use of MitraClip led to the publication of registry data this week that show why the device has enjoyed double-digit growth over a series of quarters—and why there is scope for the market to continue evolving.

“Clearly, the procedure itself is generally quite technically successful and safe. This may be the most important “finding” of this report. The introduction of transcatheter devices, of which MitraClip is the first example, transseptally into the left atrium and the ability to navigate and steer to the mitral leaflets and annulus will be of paramount importance to the future evolution of catheter-based treatment of MR,” Steven F. Bolling, M.D., a cardiac surgeon at the University of Michigan Health System, said in an editorial accompanying registry data on MitraClip.