Boston Sci Device Hits Goal in Heart Failure Trial

Boston Scientific said on Tuesday that a large clinical trial showed early intervention with implantable devices called cardiac resynchronization therapy can slow the progression of heart failure.

Chitose Suzuki / AP Boston Scientific Corp.

The study could significantly expand the market for the devices, which coordinate heart pumping through electrical pulses, beyond the sickest heart failure patients.

Shares of Boston Scientific rose sharply Tuesday after preliminary results of the the long-awaited study were released. Among rival heart-rhythm device makers, Medtronic and St. Jude Medical gained.

Boston Scientific's MADIT-CRT study of more than 1,800 patients met its main goal, finding that the CRT devices when combined with a defibrillator cut the risk of death or heart failure interventions by 29 percent compared with defibrillators alone.

The trial looked at early-stage heart failure patients who already have an defibrillator, to see whether cardiac resynchronization therapy, or CRT, can slow the progression of the condition.

Nearly 22 million people worldwide, including 5.5 million Americans, suffer from heart failure. About 70 percent of all heart failure patients are in the early stage.

The study has been highly anticipated by Wall Street because a positive result would have the potential to improve sales of more expensive defibrillators that also have the CRT feature.

Some analysts have predicted positive results would double the market for devices that combine CRT with defibrillators (CRT-D) to about 500,000 patients, boosting company profits by shifting sales to the more expensive combination products.

The CRT-D devices cost $25,000 to $33,000, while a standard defibrillator costs $20,000 to $27,000. Heart failure patients have weakened hearts that do not pump efficiently. Late-stage patients have severe limitations on everyday activities, like climbing stairs, while early-stage patients have slight symptoms or none at all.

Standard defibrillators, or ICDs, involve two electrical lead wires that extend to the heart's right ventricle. CRT-D devices add a third lead that attaches to the left ventricle, helping it coordinate pumping of the chambers and improve efficiency. When both ventricles are paced to contract at the same time, the device can reduce the symptoms of heart failure.

Researchers plan to present full results of the MADIT-CRT study later this year, after which Boston Scientific hopes to apply for U.S. approval to expand the use of the CRT-D devices to the earlier-stage group, a company spokeswoman said.

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