Switzerland-based medical implant maker Symetis is looking to make some major moves in the global transcatheter aortic valve implantation market, and the company’s not afraid to take on some of the medtech industry’s biggest players.
The company has been going head-to-head against TAVI giants Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT) for years in Europe, and Symetis is already plotting the future battle in the U.S.
Symetis just won CE Mark approval in the European Union for its Acurate neo transfemoral TAVI device, complementing the Acurate TA transapical system approved in 2011. Symetis may not have the size or tenure of some of its TAVI rivals, but the scrappy device maker isn’t to be underestimated.
"We have already proven that we can compete with these giants. According to the latest data from BIBA, a leading medical device market analysis firm, Symetis has taken 25% of the EU TA market with our Acurate TA and is the 2nd player after Edwards," CEO Jacques Essinger told MassDevice.com. "We achieved this success in less than 3 years thanks to the unique uncomplicated performance of our device, which provides the user with outstanding clinical performance and truly unmatched ease of use."
The newly approved Acurate neo is built on the same principles, and Symetis expects the product to make a big splash in Europe and Asia, Essinger added.
The company is still a few years behind in the U.S., where Edwards won FDA approval in 2011 and Medtronic got the nod earlier this year, but Symetis isn’t about to lost ground to fellow TAVI contenders St. Jude Medical (NYSE:STJ) and Boston Scientific (NYSE:BSX) take 3rd place.
"We are planning to come to the FDA in 2016 with a next generation product, based upon the unique features of the Acurate neo, which we expect to be a game-changer to address the main TAVI issue, i.e. paravalvular leak," Essinger said. "Our goal is to compete for and win the 3rd place in the TAVI landscape."