Stealthy Swiss device maker Symetis announced today that it’s launching commercial sales of its Acurate neo transfemoral transcatheter aortic valve implantation system, having just won CE Mark approval from European regulators.
The E.U. win puts Symetis in the ring with giants Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT) as the only device makers with TAVI systems on the market for both transapical and transfemoral delivery options.
The Acurate neo device joins Symetis’ Acurate TA transapical TAVI system, which won European approval in October 2011. The new Acurate neo transfemoral device won CE Mark approval based in part on results from Symetis’ clinical studies, which found 3.4% mortality at 30 days and 95% procedural success, according to a press release.
"We are delighted with the performance and safety outcomes of our CE Mark study, along with its procedural success," Symetis clinical & regulatory vice president Laura Brenton said in prepared remarks. "Reflecting an evolving European regulatory environment for medical devices, we brought over 90% of the patient cohort to the 12-month follow-up window. This is the most robust set of clinical data submitted for a TAVI CE Mark to date."
Symetis faces some particular stiff competition, with medtech titans Medtronic and Edwards already vying for top billing in the European Union. The giants have been fighting it out at conferences, in courtrooms and in the patent office to lead in TAVI, which represents a $1 billion market expected to grow to $2.5 billion by the end of the decade.
"Symetis is located smack in the middle of the global leaders in the field’s international headquarters," a company spokesperson told MassDevice.com. "Their strategy is to maintain very close relationships with physicians, and their small size allows the company to stay nimble and quickly respond to physician’s needs and feedback."