St. Jude, CardioKinetix tout impressive data at EuroPCR

The industry has descended on Paris to talk stents, valves and drug elution at EuroPCR, touting new technologies to an audience of the world's cardiovascular decisionmakers. Below are some highlights from Day Three at the conference, and be sure to check out our coverage of Day One and Day Two.

Courtesy of St. Jude Medical

St. Jude Medical ($STJ) found that its EnligHTN renal denervation device lowered systolic blood pressure by an average of 27 mmHg after one year, all with no long-term safety issues or significant changes to kidney function. The 46-patient study looked at hypertension sufferers with an average systolic blood pressure of 176 mmHg who don't respond to drug therapy. Every 20 mmHg decrease in systolic blood pressure halves the risk of cardiovascular death, St. Jude said, and EnligHTN's results demonstrate its potential to be a life-saving technology. The study, EnligHTN I, is one of 5 renal denervation trials St. Jude is running, including one involving patients with less severe hypertension, one of a second-generation device, one designed to win FDA approval and, finally, the EnligHTNment study, which tests how well renal denervation can prevent major cardiovascular events like heart attack and stroke. Results

Courtesy of Boston Scientific

Boston Scientific's ($BSX) transcatheter aortic valve, the Lotus, notched some positive results in a study of 60 patients with severe aortic valve disease. The device beat its performance endpoint for aortic valve pressure and met its safety goal, with only one patient developing moderate paravalvular regurgitation, in which blood flows the wrong direction. There were no instances of botched implantation, and the all-cause mortality rate was 1.7% after 30 days, which Boston Scientific is touting as a victory for the device. Boston Scientific plans to use the data to secure a CE mark for the valve, eventually competing with similar offerings from Medtronic ($MDT) and Edwards Lifesciences ($EW). The company acquired Lotus in its 2011 buyout of Sadra Medical. Results

Courtesy of Medtronic

In one-year data, Medtronic's In.Pact Falcon drug-eluting balloon proved superior to Boston Scientific's Taxus stent in treating patients with lesions in small coronary arteries, the company reported. The Falcon beat Taxus in preventing late lumen loss and was statistically similar in rates of major adverse cardiac events, myocardial infarction and target lesion revascularization. Nearly two-thirds of the vessels treated in the study were below 2.25mm in diameter, too small for any drug-eluting stent, Medtronic said, meaning there's a sizable unmet need among patients with small-vessel lesions that Falcon is well-suited to serve. Medtronic is using its latest positive results to help market the balloon overseas, and the CE marked implant is yet to receive FDA approval. Results

Courtesy of CardioKinetix

CardioKinetix, a 2012 Fierce 15 winner, reported that its Parachute ventricular partitioning device was safe and effective in 91 patients with ischemic heart failure, helping treat the left ventricle enlargement that can lead to repeat heart failure. After 6 months, 90% of patients were free of major adverse cardiac events and 89% improved or maintained heart functionality, the company said. The Parachute also helped reduce left ventricular volume in patients, notching 20% shrinkage in end diastolic volume and a 23% reduction in end systolic size. The positive results add to the pool of data CardioKinetix is using to promote the device overseas, where it is CE marked, and the data are part of an ongoing study targeting FDA approval in the U.S. The company raised a $44 million Series E in two tranches last year, and it plans to use that cash to fund more research and scale up its commercialization heft. Results

Courtesy of Medtronic

Finally, speaking of renal denervation, Medtronic also announced that it has completed enrollment in the Symplicity HTN-3 trial, a pivotal U.S. study designed to secure FDA approval for the company's market-leading Symplicity system. The study will chart Symplicity's safety and effectiveness on 530 patients across about 90 sites around the country, looking at rates of blood pressure reduction, major adverse events and renal artery stenosis. In addition, Medtronic has struck a deal with CMS in which the agency has agreed to evaluate Symplicity for national reimbursement coverage at the same time the FDA conducts its review, thus speeding Medtronic's path to U.S. capitalization. The company expects to win approval and launch the device in the U.S. in 2015. More

Check in tomorrow for more coverage of EuroPCR.

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