Healthcare Industry News:  Edwards Lifesciences 

Devices Interventional Cardiology

 News Release - April 4, 2011

Harvard Clinical Research Institute and Saint Luke’s Mid America Heart and Vascular Institute Complete Cost-Effectiveness Analysis for SAPIEN Transcatheter Heart Valve

Study Analysis Presented in Plenary Session at ACC

BOSTON & KANSAS CITY, Mo.--(Healthcare Sales & Marketing Network)-- The Harvard Clinical Research Institute (HCRI) and Saint Luke’s Mid America Heart and Vascular Institute (MAHVI) today announced that Matthew R. Reynolds, M.D., Director of the Economics and Quality of Life Research Center (EQOL) at HCRI, presented results of a cost-effectiveness analysis of transcatheter aortic valve replacement versus standard therapy for severe aortic stenosis, as part of the opening plenary session on April 3 at the American College of Cardiology 60th Annual Scientific Session & Expo. The analysis was performed on a specific cohort of the PARTNER Trial, which is sponsored by Edwards Lifesciences. Dr. Reynolds and David Cohen, M.D., M.Sc., Medical Director of the Health Economics and Technology Assessment (HETA) group of MAHVI, were co-principal investigators for this economic sub-study of the PARTNER Trial.

HCRI and MAHVI are each well known for their expertise in designing, implementing and evaluating clinical trials that assess the economics and comparative effectiveness of new and existing therapeutics, devices and procedures. Drs. Reynolds and Cohen are both experts in the field of health care cost-effectiveness studies, each having participated in numerous such analyses and extensively publishing on the topic.

“Information about the economic impact of this device is important, because the cohort studied included a very sick and elderly patient population, for which quality of life and cost effectiveness issues are particularly vital to understand,” said Dr. Reynolds. “Our team at HCRI is experienced in understanding, investigating and analyzing these cost-related issues, as well as working with clinical trial sponsors to conduct economic assessments that aid in the development of new medical interventions. These economic analyses are part of HCRI’s broader support of comparative effectiveness studies that provide evidence-based information to support informed medical decision-making.”

“These results clearly demonstrate that despite its high upfront cost, transcatheter aortic valve replacement is an economically attractive therapy for these patients who otherwise lack viable treatment options,” said Dr. Cohen. “New medical therapies and technologies are an important contributor to increased health care costs, so cost-effectiveness analysis is increasingly being utilized to objectively examine the relationship between the additional costs and health benefits of new devices and procedures. At MAHVI, the HETA research group seeks to improve health care by applying formal health economic analyses to a broad range of novel interventions to diagnose and treat cardiovascular disease.”

Clinical results for this cohort of the PARTNER Trial, Cohort A, were also presented as part of the plenary session at the American College of Cardiology meeting. Clinical results for Cohort B were announced by Edwards Lifesciences in September 2010.

About The Harvard Clinical Research Institute (HCRI)

The Harvard Clinical Research Institute is a non-profit academic research organization with unparalleled access to resources in clinical research. The Institute advances the research of pharmaceutical, biological, and medical device products by developing collaborations between industry and academia. HCRI’s partners include leading medical centers with worldwide recognition for high-quality medical care and state-of-the-art facilities. Its close affiliation with Harvard Medical School, Beth Israel Deaconess Medical Center and Partners HealthCare reinforces HCRI’s commitment to engaging distinguished medical practitioners in thought-provoking, industry-sponsored research. The Institute’s sponsors rely on its scientific objectivity to add unique value to the design of their studies, oversight of their research and analysis of their study data. As a leading provider of clinical trial services, HCRI plays an important role in assessing new products that improve the quality of peoples’ lives.

About St. Luke’s Mid America Heart and Vascular Institute

Saint Luke's Mid America Heart and Vascular Institute, the flagship institution of the Saint Luke’s Health System and a major teaching affiliate of the University of Missouri-Kansas City, is one of the pre-eminent cardiovascular programs in the Midwest. With more than 50 full-time cardiovascular specialists on staff, the Mid America Heart and Vascular Institute continues to provide cutting edge cardiovascular care including one of the largest heart failure/cardiac transplant programs in the country and the largest experience with transcatheter aortic valve replacement in the Great Plains region. In addition to the internationally recognized Health Economics and Technology Assessment Program, the Outcomes Research Program at Saint Luke’s Mid American Heart and Vascular Institutes is one of 4 American Heart Association Centers of Excellence in cardiovascular outcomes research and provides national and international leadership in a broad range of disciplines including quality assessment/quality improvement, health economics, patient-centered outcomes, and individualized decision making.

Source: Harvard Clinical Research Institute

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