St. Jude Medical (NYSE:STJ) reported a milestone for its Portico heart valve today, saying the 1st patient was given the transcatheter aortic valve implant via a catheter threaded through an incision in the apex of the heart’s left ventricle.
TAVI devices, used to treat aortic stenosis, are typically delivered via the femoral artery in the leg.
"The first patient implanted with the transapical delivery approach represents a significant milestone in our ongoing efforts to provide physicians a wide range of options to best treat their patients, "Frank Callaghan, president of St. Jude’s cardiovascular & ablation technologies arm, said in prepared remarks.
Last week the St. Paul-based medical device company said the European Union granted CE Mark approval for its Portico transcatheter aortic heart valve, pitting St. Jude against Edwards Lifesciences (NYSE:EW) and crosstown arch-rival Medtronic(NYSE:MDT) in the TAVI market across the pond. Another rival, Boston Scientific (NYSE:BSX), is 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."