Medtronic claims the CoreValve is the only transcatheter aortic valve implantation device available for subclavian access.
Implantation beneath the collarbone is generally preferred for patients with narrow or damaged femoral arteries. Medtronic is touting the study as evidence that the approach could be used in a much wider swath of patients.
Despite being sicker than the control group, patients who underwent the subclavian approach showed a higher procedural success rate (97.7 percent versus 96.3 percent) and lower mortality rate than the traditional femoral approach (1.5 percent versus 1.8 percent), the Fridley, Minn.-based medical device monolith announced at the EuroPCR conference today.
Today’s presentation is another feather in the cap for Medtronic’s CoreValve system. Just yesterday the company announced findings from a two-year study showing improved quality of life in patients implanted with the device. The company goes head-to-head overseas against rival Edwards Lifesciences (NYSE:EW) and its competing Sapien device, but Medtronic is about two years behind Edwards in the U.S., where Sapien is expected to hit the market by the end of this year.
OrbusNeich touts positive findings for Genous stent
For patients with an increased risk of bleeding, OrbusNeich presented findings that its Genous stent is a safe and effective alternative to a drug-eluting stent, according to multiple clinical studies.
Three-year follow-up data of 405 patients showed no new cases of definite thrombosis beyond the first year and one probable case. Revascularization rates went from 10.6 percent at one year to 14.2 percent at three years.
OrbusNeich’s Genous stents use patented cell capture technology to promote accelerated natural healing of vessel walls. OrbusNeich presented ex vivo findings that their Genous stent increased rates of endothelialization, a process that protects circulating blood cells via a thin layer of vessel wall tissue growth over a stent.
Eurocor drug-eluting balloon looks good in 12-month follow-up
Eurocor GmbH, a division of Opto Circuits (India) Ltd., announced 12-month outcomes of its DIOR drug-eluting balloon for patients suffering from in-stent restenosis caused by both bare metal and drug-eluting stents. The DIOR stent achieved 9.2 percent revascularization for patients with bare-metal stents and 14.8 percent revascularization for patients with drug-eluting stents.
The DIOR stent was not so successful for patients with narrow vessels, who showed 2.9 percent revascularization.
Medinol’s flexible bare-metal stent achieves positive findings
Medinol Ltd., a division of Johnson & Johnson’s (NYSE:JNJ) Cordis Corp., touted results from a study of its Presillion Plus bare metal stent system at nine and 12 months.
The stent, which is flexible and conforms to an artery’s shape, was successfully implanted in 98.2 percent of patients and there were not cases of thrombosis after 30 days. The device achieved 6.3 percent lesion revascularization one year after implantation.
The results of the study may widen the domain of bare-metal stenting without the risk of thrombosis or extended dual anti-platelet therapy, Medinol said in a press release.