Abbott (NYSE:ABT) today released one-year results from a study exploring the use of its Portico transcatheter aortic valve replacement system in patients with symptomatic, severe aortic stenosis, touting low rates of stroke, death and leaks between the valve and native heart tissue.
Results from the Portico 1 study were presented during a late-breaking session at the Transcatheter Cardiovascular Therapeutics conference in San Diego and published in the Journal of the American College of Cardiology, the Chicago-based company said.
“These real-world data demonstrate that Portico is safe and performs as intended to help patients suffering from severe aortic stenosis. Portico reduces the need for open-heart surgery to replace an aortic valve, and is an important part of Abbott’s mission to provide life-changing technologies to treat people with structural heart diseases,” structural heart biz chief medical officer Dr. Neil Moat said in a prepared statement.
One-year results from the real-world, multi-center 941-patient study indicated a 12.1% rate of all-cause mortality and a 6.6% rate of cardiovascular mortality. The average rate of disabling stroke was 2.2%, while the rate of myocardial infarction was 2.5%, Abbott said.
Mean aortic valve area increased from 0.72 ± 0.37 cm2 at baseline to 1.79 ± 0.48 cm2 at 30 days, durable out to one year. Rates of moderate paravalvular leak were reported at 3.9% at 30 days, down to 2.6% at one year, the company said. The proportion of patients classified with NYHA Class III or IV heart failure fell from 63.8% at the baseline to 7.7% at one year.
“Portico offers physicians the ability to safely and successfully treat patients suffering from symptomatic, severe aortic stenosis with a high level of confidence. These one-year results in a real-world setting give us assurance that Portico is an excellent and important treatment option for patients with severe aortic stenosis who are at increased risk for open-heart surgery,” principal investigator Dr. Lars Sondergaard of Copenhagen, Denmark’s Rigshospitalet said in a press release.
Abbott said that its Portico valve won CE Mark approval in the European Union in 2012, and that the company is engaged in a US pivotal study of the device. The company said it recently received approval in Europe for a sheathless introduction of the valve, which it claims improves ease of use and could lower adverse event rates.
Yesterday, Abbott reportedly received applause from the audience at TCT 2018 after releasing positive results from a clinical trial of its MitraClip heart valve device.
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