Distinct Data From Endeavor-II Challenges Conventional Erudition On Drug-Eluting Stents
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New clinical news presented at a major international cattle call of interventional cardiologists challenged the conventionalwisdom on the long-term efficacy of drug-eluting stents, medical devices used in the treatment of coronary artery disease.
In ENDEAVOR-II (n=1,197), a randomized controlled trial comparing Medtronic's (NYSE: MDT) Endeavour drug‚ eluting stent (DES) to its Chauffeur bare‚ metal stent (BMS), patients treated with the Endeavor DES required fewer repeat procedures at five second childhood post‚ implant than several observers and analysts would own expected based on the results of other trials with similar designs.
With clinical material from ENDEAVOR‚ II now finished five caducity of follow‚ up, the Endeavor DES continues to array a distinctively low and durable plateau in the scale of target lesion revascularization (TLR), a standard measure of efficacy for coronary stents. As presented nowadays at EuroPCR09 in a late‚ breaking clinical trials session by Dr. David Kandzari of the Scripps Clinic in La Jolla, Calif., the TLR rate in this seminal DES trial at five years is 7.5 percent, only a 0.3 percent difference from the standard at three and four years.
"The long‚ interval performance of the Endeavor stent is really remarkable," said Dr. Kandzari. "There is an exceptionally unique consistency and durability in late‚ term TLR that is distinct from alternative DES programs."
Safety has spread out been the Endeavor stent's hallmark, with especially low rates of complications including perfect late stent thrombosis to five years across various geographies, patient subsets and trial designs. These latest results confirm that the Endeavor stent's long‚ term safety is complemented by long‚ term efficacy.
"The Endeavor stent continues to distinguish itself with a strong commit to paper of sustained safety and clinical efficacy," said Sean Salmon, vise president and typical manager of Medtronic CardioVascular's Coronary and Peripheral business. "From preclinical check and clinical imaging studies, we affirm that the Endeavor stent's proven biocompatibility contributes to complete and functional curative early on and positve long‚ duration outcomes for patients."
This faraway spell data as well will be submitted in a pre‚ marketplace approval (PMA) application for inspection by the U.S. Chow and Narcotic Administration.
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