"In addition to the knowledge we hope to gain from this population of patients with diabetes, we are excited for the opportunity to improve the broad applicability of the MADIT S-ICD trial results by increasing the enrollment of women in this study," said Kenneth Stein, M.D., senior vice president and chief medical officer, Global Health Policy and Rhythm Management, Boston Scientific. "Moreover, the trial emphasizes our continued commitment to expanding access to all patients who may benefit from this proven technology."
The EMBLEM MRI S-ICD System has been accepted for parallel review for a new indication by the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services. The two organizations will concurrently review the MADIT S-ICD trial data as well as other relevant information to determine FDA approval and Medicare coverage of the device for patients aged 65 and older with a history of prior heart attack, diabetes and moderately reduced left ventricular ejection fraction.
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For more information on the EMBLEM MRI S-ICD System visit www.bostonscientific.com/sicd.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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