Medtronic’s Resolute Integrity DES Grabs New Indications in EU

Medtronic’s Resolute Integrity DES Grabs New Indications in EU

Medtronic‘s Resolute Integrity drug eluting stent has been cleared by the FDA for treatment of coronary artery disease. The device is built on the platform of the Integrity bare metal stent that uses a wire that is specially bent and wound like a helix to create a spring-like structure.

Resolute EN Polymer Medtronic Resolute Integrity DES Cleared in the U.S.

The device was approved in Europe about a year and a half ago.

From the announcement:

The new heart device’s FDA approval stems from the results of a global series of studies involving the Resolute DES, which showed consistently powerful clinical performance across a broad spectrum of patients –– including those with diabetes, a common contributor to coronary artery disease that complicates treatment. The Resolute DES uses the same drug-and-polymer combination as the Resolute Integrity DES.

The Resolute Integrity DES builds on the success of the market-leading Integrity bare metal stent. The Integrity platform’s rapid adoption in the United States is the result of a proprietary engineering advance called continuous sinusoid technology (CST).

CST encompasses one continuous, single strand of wire that is molded into a sinusoidal wave and then wrapped in a helical pattern and laser-fused at certain points, making each stent comparable to a flexible spring.

The global RESOLUTE clinical program consisted of a large randomized controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries. In total, the program enrolled more than 5,100 patients who received a Resolute DES; about a third (1,535) of these patients had diabetes, a proportion that mirrors the U.S. patient mix.

RESOLUTE US enrolled 1,402 patients across 128 U.S.-based clinical trial sites. It was led by Dr. Leon and his co-PIs: Laura Mauri, M.D., chief scientific officer of the Harvard Clinical Research Institute and an interventional cardiologist at Brigham and Women’s Hospital in Boston; andAlan Yeung, M.D., director of intervent ional cardiology at Stanford University School of Medicine in Palo Alto, Calif.

At one year of follow-up in RESOLUTE US, the results included low rates of target lesion failure (TLF, 4.7%), clinically-driven target lesion revascularization (TLR, 2.8%) and definite/probable stent thrombosis (def/prob ST, 0.1%). These results were achieved despite 34 percent of the patients in the study having diabetes, which typically drives higher event rates.

One year of follow-up in a pre-specified analysis of patients with diabetes who received a Resolute DES as participants in the Resolute clinical program also demonstrated low rates of TLF (6.6%), TLR (3.4%) and def/prob ST (0.3%).

In two separate large randomized controlled trials, the Resolute DES matched the safety and effectiveness of Abbott Laboratories’ Xience V® DES, which represents the market-leading DES platform in the United States.

PARIS –– May 15, 2012 –– As EuroPCR 2012 gets under way today, Medtronic, Inc. (NYSE: MDT) announced that the Resolute Integrity Coronary Stent System has received European regulatory approval for several new indications, making it the drug-eluting stent (DES) with the broadest range of approved indications in Europe.

The Resolute Integrity DES is now explicitly indicated in countries outside the United States that accept the CE mark for the following patient and lesion types: acute coronary syndromes, acute myocardial infarction, unstable angina; diabetes mellitus; bifurcations; multi-vessel disease; total occlusions and chronic total occlusions; and in-stent restenosis. All but the indications for diabetes and multi-vessel disease are new.

Two of the studies that contributed to the European regulatory authority’s approval of these indications, RESOLUTE All Comers and RESOLUTE International, are the subject of several new data presentations at EuroPCR, which attracts thousands of physicians from around the world who specialize in cardiovascular interventions.

RESOLUTE All Comers: Three-Year Results

Three-year results from RESOLUTE All Comers, a randomized controlled trial comparing the Resolute DES to the Xience V DES from Abbott Laboratories, showed that the Medtronic device continues to match its chief competitor on important measures of safety and efficacy in long-term follow-up.

RESOLUTE All Comers enrolled nearly 2,300 patients, with very few exclusion criteria, at 17 centers in Europe and Israel. As a result, 66 percent of the “real-world” patients in the study were considered complex, which is representative of standard clinical practice.

RESOLUTE All Comers used the primary endpoint preferred by the U.S. Food and Drug Administration (FDA) for studies of drug-eluting stents: target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and clinically-driven target lesion revascularization, at one year of follow-up.

Presented today by Prof. Stephan Windecker of Bern University Hospital in Switzerland, a co-principal investigator of the study, the rates of TLF at three years in RESOLUTE All Comers remain equivalent for the two devices: 13.1% for Resolute; 12.4% for Xience V (p=0.614). Additionally, the rates of definite/probable stent thrombosis at three years were low, with no statistically significant difference. Rates of definite/probable very late stent thrombosis (VLST) were the same for the two devices (0.5% vs. 0.5%, p=1.00).

“RESOLUTE All Comers has amassed an invaluable data set to guide stent selection for patients with coronary artery disease, regardless of its complexity,” said Prof. Windecker. “The rigorous design and conduct of the study, which enrolled a majority of complex patients and has lost less than two percent of patients to follow-up, makes the results highly relevant to the contemporary clinical practice of interventional cardiology worldwide.”

Prof. Windecker’s co-PIs for RESOLUTE All Comers are Prof. Patrick Serruys, M.D., Ph.D., of the Thoraxcenter at Erasmus University in Rotterdam, the Netherlands, and Prof. Sigmund Silber, M.D., of the Heart Catheterization Centre in Munich, Germany.

Pooled Analyses: Bifurcation Lesions and In-Stent Restenosis at Two Years

Two-year results from RESOLUTE All Comers and RESOLUTE International in patients with bifurcation lesions and in-stent restenosis will also be presented at EuroPCR. These two subsets are common in standard clinical practice, together accounting for approximately 20–25 percent of patients who receive stents.

The pooled data set on bifurcation lesions, which remain a therapeutic challenge for the interventional community, will be presented on Thursday by Dr. Ran Kornowski from Rabin Medical Center and Tel Aviv University in Israel.

As the only DES on the market with an indication for treating bifurcated lesions, the Resolute DES performed extremely well in this patient subset. Of the 702 patients with bifurcated lesions, the use of the Resolute DES and its excellent side branch access resulted in a low TLF rate of 12.6 percent at two years (and 10.4 percent at one year).

The pooled data set on in-stent restenosis (ISR) will be presented on Friday by Dr. Gert Richardt from the Segeberger Clinic’s Heart Center in Germany. Patients presenting with ISR have been associated with worse outcomes and a higher rate of repeat procedures than patients who are treated for de novo lesions. At two years, the 281 ISR patients treated with a Resolute DES had a TLF rate of 17.5 percent, which is considered low for patients with this challenging lesion type. The TLF rate at one year was 10.8 percent.

In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

ABOUT MEDTRONIC

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Medtronic has received expanded clearance for a bunch of new indications for its flagship Resolute Integrity drug eluting coronary stent in countries using the CE Mark. It was previously labeled for use in patients with diabetes and multi-vessel disease, but is now also approved for acute coronary syndromes, acute myocardial infarction, unstable angina, bifurcations, in-stent restenosis, total occlusions and chronic total occlusions.

Recent clinical study results, according to the latest company’s announcement:

Three-year results from RESOLUTE All Comers, a randomized controlled trial comparing the Resolute DES to the Xience V DES from Abbott Laboratories, showed that the Medtronic device continues to match its chief competitor on important measures of safety and efficacy in long-term follow-up.

RESOLUTE All Comers enrolled nearly 2,300 patients, with very few exclusion criteria, at 17 centers in Europe and Israel. As a result, 66 percent of the “real-world” patients in the study were considered complex, which is representative of standard clinical practice.

RESOLUTE All Comers used the primary endpoint preferred by the U.S. Food and Drug Administration (FDA) for studies of drug-eluting stents: target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and clinically-driven target lesion revascularization, at one year of follow-up.

Presented today by Prof. Stephan Windecker of Bern University Hospital in Switzerland, a co-principal investigator of the study, the rates of TLF at three years in RESOLUTE All Comers remain equivalent for the two devices: 13.1% for Resolute; 12.4% for Xience V (p=0.614). Additionally, the rates of definite/probable stent thrombosis at three years were low, with no statistically significant difference. Rates of definite/probable very late stent thrombosis (VLST) were the same for the two devices (0.5% vs. 0.5%, p=1.00).

Two-year results from RESOLUTE All Comers and RESOLUTE International in patients with bifurcation lesions and in-stent restenosis will also be presented at EuroPCR. These two subsets are common in standard clinical practice, together accounting for approximately 20–25 percent of patients who receive stents.

The pooled data set on bifurcation lesions, which remain a therapeutic challenge for the interventional community, will be presented on Thursday by Dr. Ran Kornowski from Rabin Medical Center and Tel Aviv University in Israel.

As the only DES on the market with an indication for treating bifurcated lesions, the Resolute DES performed extremely well in this patient subset. Of the 702 patients with bifurcated lesions, the use of the Resolute DES and its excellent side branch access resulted in a low TLF rate of 12.6 percent at two years (and 10.4 percent at one year).

The pooled data set on in-stent restenosis (ISR) will be presented on Friday by Dr. Gert Richardt from the Segeberger Clinic’s Heart Center in Germany. Patients presenting with ISR have been associated with worse outcomes and a higher rate of repeat procedures than patients who are treated for de novo lesions. At two years, the 281 ISR patients treated with a Resolute DES had a TLF rate of 17.5 percent, which is considered low for patients with this challenging lesion type. The TLF rate at one year was 10.8 percent.

Source : http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1337104533932&lang=en_US

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