The safety profile of Medtronic’s (NYSE:MDT) Resolute drug-eluting stent is at least as good as Abbott’s (NYSE:ABT) market-leading Xience V DES and slightly better than Medtronic’s own Driver bare-metal stent, according to a study Medtronic is touting at the European PCR conference in Paris.
The Resolute device, which is coated with the drug zotarolimus, delivered similar performance as the Xience stent and roughly the same rates of cardiac death, heart attack and blood clots after two years, according to the 5,000-patient study. The Resolute stent posted better rates for cardiac death, heart attack and blood clots than its bare-metal cousin.*
The Fridley, Minn.-based medical device giant gathered data on its Resolute stent from five studies in the U.S., Japan and the U.K. Data on the Driver stent was borrowed from the control arm of a prior Medtronic study and the Xience V data was pulled from a European all-comers trial in Europe.
It’s the second year in a row that Medtronic has vaunted Resolute’s comparability to the Abbot device at the EuroPCR conference.
Medtronic has more good news about CoreValve
For the third day this week, Medtronic officials took to the podium at the EuroPCR conference to present positive findings for their CoreValve aortic valve replacement device.
According to a meta-analysis summarizing European data from more than 2,000 patients, CoreValve is a safe alternative for high-risk patients unable to undergo surgical aortic valve replacement, the company said.
Although CoreValve is already being sold in Europe, it’s only approved for investigational purposes in the U.S., where the product has not been immune from controversy. Edwards LifeSciences Corp. (NYSE:EW) accused the company of patent infringement after Medtronic acquired CoreValve for $700 million in 2009.
Medtronic has said that CoreValve revenue from international operations “continues to nearly double year-over-year and our share remained stable at approximately 50 percent.”
Edwards touts one-year transcatheter study results
Not to be outdone, Edwards Lifesciences (NYSE:EW) presented findings for its Sapien transcatheter aortic valve implantation device, which goes head-to-head overseas with Medtronic’s CoreValve device.
The Sapien device showed successful one-year outcomes in high-risk or inoperable patients in its first two years of commercialization, Edwards said. One-year survival rates were 80.1 percent for patients who received transfemoral valve replacement and 74.2 percent for patients who received transapical replacement.
Edwards’ device is expected to hit the U.S. market later this year, about two years ahead of CoreValve. Medtronic has touted CoreValve often during this year’s EuroPCR meeting.
Boston Scientific boasts "exceptional safety and effectiveness" for its Promus stent system
Boston Scientific Corp. (NYSE:BSX) announced positive clinical results from a 12 month small-vessel study of its Promus Element stent system.
The study showed no instances of myocardial infarction, stent thrombosis, or ischemia-driven target lesion revascularization after one year in 94 patients with small vessels. Boston Scientific expects Food & Drug Administration approval for the Promus device mid-2012, according to a release.
The Promus device competes with Abbott Laboratories’ (NYSE:ABT) Xience V stent (a previous iteration of the Promus platform was a private-label version of the Xience V, made by Abbott and marketing under BSX’s Promus umbrella). Boston Scientific presented results of a study comparing its latest Promus device, which is made of a platinum-chromium alloy, during April’s conference of the American College of Cardiology.
Stents: Less thrombosis with biodegradable polymers
Drug-eluting stents with biodegradable polymers result in half as many cases of stent thrombosis (1.2 percent) compared to stents with permanent polymers (2.1 percent), according to a new meta-analysis presented at the conference today.
"With a biodegradable polymer DES, when we analyze large numbers of patients, we can see a clear signal toward reduced late adverse events, and we see overall improved cardiovascular outcomes," said study coauthor Dr Robert Byrne of Deutsches Herzzentrum in Munich, Germany.
The meta-analysis compared two different drug eluting stents and found consistent results. The difference is small, but this is the first time a clear difference has been detected, Byrn said.
St. Jude says FFR improves patient outcomes and saves money
St. Jude Medical Inc. (NYSE:STJ) announced that hospitals in the U.K., France, and Italy can save lives as well as up to $1,200 per patient by using Fractional Flow Reserve, a measure that indicates the severity of blood flow blockages in patients with coronary artery disease.
The results are part of an ongoing effort to provide country-specific cost effectiveness and health outcome analysis based on previous St. Jude findings and data from each country.
In May St. Jude touted similar findings for Germany and announced plans to study six additional European countries and Canada. St. Jude released data for the U.S. in December.
*Correction, May 23, 2011: This article originally stated that that the Resolute stent was not as effective as the bare-metal stent in clinical trials. The Resolute stent showed lower rates of target lesion revascularization in the study. Return to the corrected sentence.
