St. Jude Medical (NYSE:STJ) said the European Union granted CE Mark approval for its Portico transcatheter aortic heart valve, pitting St. Jude against Edwards Lifesciences (NYSE:EW) and arch-rival Medtronic (NYSE:MDT) in the TAVI market across the pond.
The St. Paul-based medical device company touts the 23mm Portico as the only TAVI device on the market designed to be re-positionable to minimize the paravalvular leakage associated with older TAVI valves, such as Edwards’ Sapien and Medtronic’s CoreValve.
"The European approval of the Portico transcatheter valve signals the imminent availability of a next-generation treatment option that can help improve quality of life for patients with diseased or damaged aortic heart valves," St. Jude’s president of cardiovascular and ablation technologies Frank Callaghan said in prepared remarks. "It also represents a key milestone for St. Jude Medical’s transcatheter heart valve program, and exemplifies our focus on developing technologies that advance the practice of medicine."
The across-the-pond nod follows positive results from a first-in-human clinical trial of the Portico device, presented at the Transcatheter Cardiovascular Therapeutics earlier this month.
St. Jude said it’s planning to launch a European study of a larger size of the Portico valve this year.
St. Jude now faces a pair of entrenched competitors in Europe and another rival, Boston Scientific (NYSE:BSX), waiting in the wings along with several smaller contestants. Medtronic’s CoreValve TAVI was first to market, hitting European shelves in 2007. Edwards Lifesciences wasn’t far behind, putting its Sapien TAVI in the EuroZone a few months later and beating CoreValve to the U.S. market late last year.
Boston Scientific launched a new clinical trial of its Lotus valve in October, expecting to use the results to support a bid for European CE Mark and other international regulatory approvals. Then there’s Direct Flow Medical and its eponymous device, expected to launch a CE Mark trial during the 1st quarter of 2013 and a U.S. IDE trial later that year. Last month Direct Flow unveiled 30-day results for its namesake, touting reduced valve leakage and procedure-related complications.
Other players include JenaValve and its self-named device and Symetis’ Acurate valve, both of which won CE Mark approval in September 2011.
Edwards has the only TAVI approved for the U.S. market and is readying 2nd- and 3rd-generation models of its Sapien valve and its 4th-generation Centera, which Leerink Swann healthcare investment bank analyst Danielle Antalffy sees entering clinical trials for CE Mark approval "before year-end."