WASHINGTON (Reuters) - Boston Scientific Corp won U.S. approval on Thursday to promote three of its implanted cardiac devices for broader use among patients with heart failure.
The Food and Drug Administration cleared the company's Cardiac Resynchronization Therapy Defibrillators, or CRT-Ds, for certain patients with heart failure who have no symptoms or only mild symptoms.
CRT-Ds are approved now for treating the most advanced stages of heart failure, but a Boston Scientific study showed they could also help healthier patients.
Wachovia analyst Larry Biegelsen said the approval posed "a modest market opportunity which is already in our model."
"We think many physicians are waiting for the indication before implanting CRT-Ds in these patients," Biegelsen said in a research note.
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.
The FDA approved the CRT-D devices for heart failure patients with an abnormality known as left bundle branch block, a condition that occurs when activation and contraction of the left ventricle is delayed.
The agency said the devices should be used "as an addition to, not a replacement for, heart failure drug therapy."
As a condition of approval, Boston Scientific must run two post-approval studies to further study long-term effects, the FDA said.
"We are extremely pleased with the FDA's decision to expand the indication for Boston Scientific CRT-Ds, which substantially broadens the population of heart failure patients who can benefit from this therapy," Hank Kucheman, an executive vice president at the company, said in a statement.
The CRT-D devices cost about $25,000 to $35,000, or about $7,000 to $8,000 more than a standard ICD.
(Reporting by Lisa Richwine; editing by Andre Grenon)