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St Jude Medical to Resume Portico Heart Valve Implants
CE Mark has been reinstated to St. Jude Medical's TAVR device, which means the company can resume selling its implants in Europe soon.
March 12, 2015
2 Min Read
St. Jude Medical's CE Mark for its Portico heart valve has been reinstated, a spokesman for the Minnesota company confirmed Thursday.
Back in September, out of caution, the medical device maker paused implanting the Portico transcatheter heart valve in patients after imaging data in a small number of cases performed 30 days after the implant in the U.S. pivotal trial showed reduced valve leaflet mobility.
Now that the CE Mark has been reinstated, St. Jude can begin to resume selling the device in Europe. TAVR devices are meant to repair or replace diseased heart valves.
"Reviews of the Portico valve by St. Jude Medical’s global physician advisors, core laboratories, independent experts and regulatory bodies found no excess rate of clinical events associated with either Portico or control valves exhibiting the leaflet motion observation and patients with this leaflet motion observation were found to be asymptomatic," said Justin Paquette, a spokesman for the company's Chronic Pain, Movement Disorders, Structural Heart and Vascular Disease businesses, in an email.
He added that St. Jude is in discussions with the FDA to resume its pivotal trial in the U.S., which was announced in May.
St. Jude Medical is not the only company testing a TAVR device in the U.S. In late September, Boston Scientific announced that it had implanted the first patients with its version of the TAVR device - the Lotus heart valve.
Meanwhile, Edwards Lifesciences, which was the first to race across the FDA finish line in November 2011 with its Sapien system, dominates the U.S. market with Medtronic coming in second with its CoreValve, which was approved in January last year.
The data from various clinical trials have been very positive, so much so that analysts believe the overall market will continue to be expanded as more physicians adopt the less invasive alternative to open heart surgery.
But the question remains to be answered whether the market will be large enough to support four players.
[Photo Courtesy of St. Jude Medical]
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