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Medtronic, Abbott Talk Up DES Data In Anticipation Of 2008 Launches

This article was originally published in The Gray Sheet

Executive Summary

Medtronic and Abbott took advantage of the TCT conference in Washington, D.C., to announce encouraging data on the two drug-eluting stents expected to be launched in the U.S. in early 2008

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Research In Brief

Abbott's ABSORB trial: Abbott launches the second phase of the ABSORB clinical trial of its bioabsorbable everolimus-eluting coronary stent. The trial will enroll 80 patients at 10 centers in Europe, Australia and New Zealand. The first patient was enrolled at Onze Lieve Vrouw Ziekenhuis Hospital in Aalst, Belgium, the company announced March 24. The company has enhanced the deliverability and vessel support of the stent since the first phase of ABSORB, which treated 30 patients with coronary artery disease. At two years post-procedure, the stents implanted in phase I were completely absorbed by the patients' bodies. In phase one, the adverse event rate was 3.6% after two years post-implant with no stent thromboses. There were no new major adverse events from six months to two years (1"The Gray Sheet" Oct. 29, 2007, p. 6)

Research In Brief

Abbott's ABSORB trial: Abbott launches the second phase of the ABSORB clinical trial of its bioabsorbable everolimus-eluting coronary stent. The trial will enroll 80 patients at 10 centers in Europe, Australia and New Zealand. The first patient was enrolled at Onze Lieve Vrouw Ziekenhuis Hospital in Aalst, Belgium, the company announced March 24. The company has enhanced the deliverability and vessel support of the stent since the first phase of ABSORB, which treated 30 patients with coronary artery disease. At two years post-procedure, the stents implanted in phase I were completely absorbed by the patients' bodies. In phase one, the adverse event rate was 3.6% after two years post-implant with no stent thromboses. There were no new major adverse events from six months to two years (1"The Gray Sheet" Oct. 29, 2007, p. 6)

Industry Presents Wish List For DES Guidance At CRT Conference

FDA's forthcoming guidance on drug-eluting stents should provide specific requirements for preclinical, clinical and postmarket studies to help manufacturers get safe products to market quickly, according to stakeholders

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