FDA okays three defibrillators to treat heart failure
The United States Food and Drug Administration announced Spet 16 it has approved three cardiac resynchronization therapy defibrillators indicated to treat certain heart failure patients.
The three defibrillators, all made by Boston Scientific Corp, are indicated to treat patients with an abnormality known as left bundle branch block, which occurs when there is delayed activation and contraction of the left ventrile.
These defibrillators perform dual fucntions that are provided otherwise by two devices, an implantable cardioverter defibrillator and cardiac resynchronization therapy. Because of this, these devices can both sense dangerous abnormal heart beat and then attempt to correct the abnormal heart rhythms, and generate small electrical impulses to coordinate the beating of the left and right ventricles so that they can pump blood normally.
These devices have been tested for three years among 1820 patients who participated in a Multimeter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy clinical study.
The study results showed patients who had left bundle branch block had their risk of death and heart failure reduced by 57 percent, compared with those who used implantable cardioverter defibrillator alone.
The FDA said these defibrillators caused complications. The agency did not say what complications they may cause, but only said the complications are acceptable. It advised physicians should tell their patients the potential adverse complications.
The company will have to conduct two post-approval studies, one on complications and long-term mortality benefits and the other on long term mortality benefits of these devices compared to implantable cardioverter defibrillator alone, according to the FDA.
A healthy lifestyle may help reduce the heart risk in most cases.
What may potentially help reduce the risk of heart failure include vitamin D, plant-based diet, whole grain cereals, grapes, and vitamin K among other things.
What may increase the risk of heart failure include sleep apnea, diabetes drug rosiglitazone, larger waistline, physical inactivity, anti-osteoporosis drugs bisphosphonates, cancer drug Avastin, and statins.
By David Liu
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