The American College of Cardiology's annual scientific summit made for a busy weekend in the medical device world. We've rounded up some highlights from the annual expo.
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| Courtesy of Medtronic |
Medtronic ($MDT) unveiled 24-month data from its FDA-targeted trial of the renal denervation device Symplicity. On a two-year follow-up, patients treated with Symplicity maintained the reduction in blood pressure charted in 6-, 12-, and 18-month check-ins, further establishing the device's efficacy, Medtronic said. Uncontrolled hypertension is a leading cause of cardiovascular events, the company said, and timing the latest data release with ACC is part of its effort to convince physicians of the investigational Symplicity's merits. More
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| Courtesy of Edwards Lifesciences |
Edwards Lifesciences ($EW) is working to get a next-generation heart valve, the Sapien XT, FDA approved, and, in a new study, the device posted similar one-year outcomes to the on-the-market Sapien but with fewer reported vascular events. Sapien XT was designed to reduce complications in transcatheter aortic valve replacement procedures, and the latest data come from a study of 560 inoperable patients with severe aortic stenosis. Next, Edwards will look at less-severe patients and submit results from both cohorts to the FDA. More
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| Courtesy of Boston Scientific |
Boston Scientific ($BSX) revealed data demonstrating that its Promus Element drug-eluting stent beats out Abbott Laboratories' ($ABT) Xience V device in a three-year study. Promus Element posted a 3.5% target lesion revascularization rate, lower than Xience V's 4.9%, and Boston Scientific's stent reported a significant reduction in rates of emergency stenting, required in 5.9% of cases versus Abbott's 9.8%. Cutting back on emergency stenting lowers the average cost of the procedure, Boston Scientific said, and the company is likely to underline those results as it battles with Abbott for market share. More
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| Courtesy of Terumo |
Terumo is gunning for Abbott's spot in the stent world, too, unveiling data demonstrating that its dissolving-polymer Nobori device measured up to Xience in a one-year study. Looking at more than 3,200 patients, Terumo found Nobori to match Xience in rates of repeat procedure, clot formation and efficacy. As Reuters notes, Xience holds a 50% share of the market for stents in Terumo's home country of Japan, so this latest slab of data may help level the playing field until Abbott is able to commercialize Absorb, its investigational fully resorbable device. More
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| Courtesy of Abbott Laboratories |
Speaking of which, Abbott Laboratories ($ABT) released three-year results for Absorb, demonstrating a major adverse cardiac event rate of 10% in a study of 101 patients, numbers Abbott says are about even with best-in-class drug-eluting stents. In a subset of 45 patients, Abbott found improvements in vessel movement and a 7.2% increase in late lumen gain, the area inside the stented vessel. Abbott says those results are unique to Absorb and its dissolving polymer, giving it a long-term leg up on metallic devices. Absorb is available overseas, and Abbott is in the midst of a U.S. trial targeting FDA approval. More
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| Courtesy of Stentys |
Stentys posted positive results for its investigational Self-Apposing Stent, designed to treat acute myocardial infarction. In one-year results of a study of 1,000 patients, Stentys' self-expanding device posted a 9.3% major adverse cardiac event rate, below the 11.1% average among conventional stents, and a cardiac death rate of 2.0%, compared to an average of 3.9% with other technologies. The latest study was designed to boost Stenty's adoption in Europe, and the company is looking forward to launching a large-scale U.S. trial in pursuit of FDA approval. More
Find the rest of our ACC 13 coverage here.