CRT-D Indication Expanded to All Heart failure Patients

 

September 17, 2010

The U.S. Food and Drug Administration (FDA) expanded the indication for three cardiac resynchronization therapy defibrillators (CRT-D) to all classes of heart failure patients. The devices, all offered by Boston Scientific, are now available for use in all New York Heart Association (NYHA) classes of heart failure to help prevent or slow the advancement of heart failure. Previously CTR-Ds were only indicated for class III and IV patients. The new use is specifically for patients with an abnormality known as left bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. The three devices are intended to treat patients with left bundle branch block (LBBB) who have either mild heart failure or heart failure with no apparent symptoms. The FDA based its approval on the results of the 1,820-patient the Boston Scientific-sponsored Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) clinical study. The study which followed 1,820 patients for an average of nearly three years at 110 centers in the United States, Europe, Canada, and Israel. It compared CRT-D therapy to ICD-only therapy in specific heart failure patients to determine whether it reduced the risk of death and heart failure. In patients with left bundle branch block, who represented 70 percent of the study group, CRT-D showed a reduction in the risk of death and heart failure by 57 percent, as compared to ICD alone. The rate of complications was considered to be acceptable by the FDA for this device, however, physicians should adequately inform patients about potential complications. For more information: www.bostonscientific.com

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