Boston Scientific Corp. has moved closer to winning U.S. clearance to promote implanted cardiac devices for patients in earlier stages of heart failure.
A government advisory panel unanimously urged approval of the company's Cardiac Resynchronization Therapy Defibrillators, or CRT-Ds, for patients with heart failure who have no symptoms or only mild symptoms.
The recommendation, if adopted by the Food and Drug Administration, could help Boston Scientific boost future CRT-D sales. The company suspended sales of the devices this week after failing to tell regulators about manufacturing changes.
CRT-Ds are approved now for treating the most advanced stages of heart failure, but a Boston Scientific study showed they could also benefit healthier patients.
Nearly 22 million people worldwide have heart failure, in which the heart struggles to pump blood around the body, and early-stage patients make up about 70 percent of the total.
CRT-D devices pair a pacemaker that coordinates heart pumping with an implanted cardioverter defibrillator (ICD) to shock the heart back into normal rhythm if needed.
A Boston Scientific study called MADIT-CRT showed patients fared better with a CRT-D as opposed to an ICD alone. The CRT-D reduced hospitalizations from heart failure and other complications by about 42 percent.
Results from the trial of 1,800 people with early heart failure were released last year.
For the healthier patients, the FDA panel said use should be limited to people with an electrical problem in the heart known as a left bundle branch block. Boston Scientific said about 70 percent of patients it studied had that problem.
FDA reviewers asked the panel to consider that some device-related complications were higher with CRT-Ds. The advisers said that risk was acceptable.
"The benefits of this therapy outweigh the side effects," said Dr. JoAnn Lindenfeld, a panel member and cardiologist at the University of Colorado Health Sciences Center.
Boston Scientific was pleased with the panel decision, said Dr. Kenneth Stein, a senior vice president in the company's cardiac rhythm management business. "We think the panel made a well-informed decision," he told reporters.
The CRT-D devices cost about $25,000 to $35,000, or about $7,000 to $8,000 more than a standard ICD.
The company has not said when it will resume sales of CRT-Ds and ICDs after the suspension announced on Monday. The FDA panel's chairman told members not to let the recall influence their decision on the proposed wider use.
© 2012 Thomson/Reuters. All rights reserved.