FDA reviews Boston Science request to extend device approval to mild heart failure patients

FDA questions new use for Boston Science device

WASHINGTON — The Food and Drug Administration said Tuesday a heart device from Boston Scientific appears effective for a new group of patients, though questions remain about the accuracy of the company’s study of the device.

Boston Scientific has asked the FDA to approve its heart rhythm device to treat mild heart failure, a new use that could expand the market for the devices by millions of patients.

Results from the company showed the device achieved its main goal of reducing hospitalization and other negative outcomes from heart failure.

But in an online review, the FDA suggested the patients Boston Scientific studied were less healthy than typical patients with the condition. As a result, the true benefits of the device may have been overstated, according to the agency.

The FDA posted its review of the company’s application ahead of a panel meeting Thursday.

The device under review combines a defibrillator, which shocks the heart to correct irregular heart beats, with a resynchronization device, which coordinates the pumping of the heart’s lower chambers.

The two-in-one device, known as a cardiac resynchronization therapy defibrillator, is currently approved for patients with moderate to severe heart failure. Patients with the condition cannot adequately pump blood throughout their body.

A Boston Scientific study showed that patients implanted with a resynchronization defibrillator were 34 percent less likely to develop heart failure than patients who only received a defibrillator. Researchers tracked more than 1,800 patients for more than four years.

FDA noted in its review that about 40 percent of patients in the trial had already been hospitalized for heart failure, suggesting they were more ill than the typical patient with the condition.

“As a result, the FDA is concerned that the reduction in all-cause mortality and heart failure might be less significant … in a commercially available setting, especially in patients who were not previously hospitalized for heart failure,” states the FDA review.

FDA scientists also noted that patients implanted with a synchronization device experienced slightly more adverse side effects than those with defibrillators.

The agency also noted a disparity in effectiveness between patients with varying degrees of heart failure. For instance, patients with the mildest classification of heart failure did not show a significant reduction in negative symptoms, but those with a slightly higher diagnosis did.

The FDA will ask a panel of outside cardiologists on Thursday to recommend which patients should receive the device.

The agency is not required to follow the advice of its panel, though it often does.

Sales growth of heart-pacing devices has been flat in recent years due to market saturation and safety concerns involving recalled devices. Boston Scientific Corp. and competitors Medtronic Inc. and St. Jude Medical Inc. are targeting patients with mild heart failure as the potential future market for their devices.

Cardiac pacing devices are implanted just under the skin of the chest and attach to the heart with insulated wires. The devices use electrical pulses and jolts to keep the heart beating steadily.

In the U.S., about 60,000 patients with severe heart disease get the devices every year, out of 5.5 million people who have heart failure. More than 3.8 million of those patients have mild to moderate heart failure.

Shares of Natick, Mass.-based Boston Scientific climbed 32 cents, or 4.7 percent, Tuesday to $7.12 in afternoon trading.

A day earlier shares hit a 52-week low after the company unexpectedly announced it would halt all sales of defibrillators. The sales suspension was apparently due to a documentation problem involving paperwork that was not filed with the FDA. The error was unrelated to this week’s FDA review.