|St. Jude's Portico transcatheter aortic heart valve showed promising early data.--Courtesy of St. Jude|
St. Jude Medical ($STJ) is celebrating promising early international data from its Portico transcatheter aortic heart valve, showing that most patients with the implant experienced major benefits after a month.
Portico won a CE mark for its 23-mm size back in November 2012, and St. Jude is seeking a similar designation for the 25-mm size. European regulators are now reviewing data from the company's expanded Portico TF CE Trial intended to support approval. The Minnesota device company presented preliminary results Oct. 28 at the Transcatheter Cardiovascular Therapeutics 2013 conference in San Francisco.
Underscoring how competitive the TAVR space is becoming, rival Boston Scientific ($BSX) announced earlier in the day that it won a CE mark for its Lotus TAVR implant.
St. Jude said most patients showed an improvement in heart function with Portico, and that the preliminary data demonstrated a "very low" rate of complications including major strokes or death (2.4% and 3.6%, respectively). Just 6% of patients reported vascular complications. What's more, after 30 days, more than 84% of patients in the study were ranked as having class I or class II heart failure, up from nearly 78% diagnosed with Class III or IV heart failure at baseline.
Researchers used the Portico 23-mm and 25-mm valves on 83 patients with severe aortic stenosis who were deemed high-risk for traditional open-heart valve replacement surgery. They suffered from severe aortic stenosis, in which the aortic valve narrows and blocks blood flow from the heart. Surgeons implanted Portico through a catheter by way of an incision in the femoral artery.
In addition to Boston Scientific, St. Jude must also compete with Edwards Lifesciences ($EW), which leads the global market with its Sapien valves. Medtronic ($MDT) also has international approval for its CoreValve and Engager devices, though the company has faced some setbacks in a ferocious patent battle with Edwards over CoreValve. 2013 Fierce 15 winner JennaValve has also developed its own novel TAVR implant and is using significant VC cash to expand European adoption of its device.
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