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| | | | Medtronic Announces FDA Approval of Expanded Labeling for Its Cardiac Resychronization Therapy CRT Mar 22nd 2006
Biventricular Pacing Systems. Change based on landmark CARE-HF study sub-analyses presented at the 2006 American College of Cardiology Annual Scientific Session... 
also demonstrate CRT with defibrillation therapy is more cost-effective than previously estimated.
Medtronic, Inc. (NYSE: MDT) today announced United States Food and Drug Administration (FDA) clearance of expanded labeling for its cardiac resynchronization therapy (CRT) biventricular pacing systems. The labeling revision reflects new key clinical benefits of Medtronic CRT systems including reduced risk of all-cause mortality and unplanned heart failure or cardiovascular hospitalization, along with previously established outcomes of patients’ reduction in NYHA Class, improved quality of life, and improved exercise capacity, among others.
The FDA’s labeling expansion was based on the results of CARE-HF (Cardiac Resynchronization in Heart Failure), a landmark clinical study sponsored by Medtronic. The study results, which were first presented during a late-breaking clinical trial session at the American College of Cardiology (ACC) Annual Scientific Session in March 2005 and concurrently published in The New England Journal of Medicine, demonstrated (beyond the benefits already established in previous clinical trials) that CRT reduces hospitalizations and saves lives in many patients with moderate or severe heart failure and poor heart pumping function. In the study, CRT was shown to reduce all-cause mortality by 36 percent and unplanned hospitalizations for worsening heart failure by 52 percent. Subsequent analyses, presented at the European Society of Cardiology in September 2005, of the average three-year randomized results indicated a 40 percent reduction in all-cause mortality, 45 percent reduction in heart failure death, 45 percent reduction in sudden cardiac death, and a sustained improvement in the heart’s pumping function.
“This is great news and absolutely appropriate given the overwhelming evidence in support of CRT therapy,” said William T. Abraham, MD, director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center. “The revised labeling, which considered the CARE-HF data, provides further validation that CRT and CRT defibrillator systems should be routinely used in patients with moderate to severe heart failure.”
Additional CARE-HF model-based analyses, presented this week at the 2006 meeting of ACC in Atlanta, found that lifetime treatment with cardiac resynchronization therapy is highly cost effective. Compared to optimal medical therapy, CRT is shown to be highly cost-effective at $6,131 per quality adjusted life year (QALY). Typically, treatments under $50,000 per QALY gained are considered to be cost-effective. The analyses showed that CRT plus defibrillation, further reducing incidences of sudden cardiac death among heart failure patients at increased risk, is also highly cost-effective therapy at $14,308 per QALY.
“Medtronic is extremely pleased with the FDA’s labeling revision for our CRT therapies as few other heart failure treatments have had such a dramatic effect on all-cause mortality and quality of life improvements,” said David M. Steinhaus, M.D., medical director of Medtronic Cardiac Rhythm Management. “Medtronic’s leadership in and commitment to clinical research, through sponsorship of landmark studies such as CARE-HF, is definitively advancing the standard of care for many heart failure patients around the world.”
Medtronic Inc. http://wwwp.medtronic.com
Mar 22nd 2006
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