How 2019 Will Define TAVR for Years to Come

There have been some pretty significant developments in the transcatheter aortic valve replacement market over the past few months. It’s safe to say it’s not going to be business as usual for TAVR in the coming years. One of the biggest developments in the market was FDA’s approval of Boston Scientific’s Lotus Edge valve in April. The approval did not come as a shock as the Marlborough, MA-based company communicated in August of 2018 that the nod from FDA would come near the middle of 2019. The approval was truly a game-changer because it meant there would be a third medtech company with a TAVR device available in both the U.S. and Europe. For years Edwards Lifesciences and Medtronic had been the only companies with TAVR systems commercially available in both Europe and the U.S. Analysts called it a “duopoly.” Irvine, CA-based Edwards has long been considered a TAVR pioneer because it secured a nod from FDA for the Sapien Valve in 2011. Medtronic was able to get into the TAVR market through its more than $700 million acquisition of Corevalve in The Dublin-based company won FDA approval for Corevalve in 2014. Lotus Edge has often been called one of the most-watched products in Boston Scientific’s pipeline. The device has drawn interest from the medical and Wall Street analyst communities because the Lotus brand was known for having low rates of paraval...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news