ANALYSIS - Industry sees big boost from heart failure study

By Debra Sherman

CHICAGO (Reuters) - Medical technology executives are betting a clinical trial of early-stage heart-failure patients could double the market for more expensive implantable devices, but some doctors and analysts predict a significant increase in implants may take several years.

At issue is the multibillion-dollar market for cardiac resynchronization therapy devices (CRT), which coordinate heart pumping through electrical pulses and are critical products for Boston Scientific Corp, Medtronic Inc and St Jude Medical Inc. CRT devices have proven to decrease mortality in late-stage heart failure patients when combined with an implantable defibrillator, which slows a dangerously fast heart beat.

The Boston Scientific-sponsored study, dubbed MADIT-CRT, involves 1,820 early-stage heart failure patients who already have a defibrillator. Should MADIT-CRT show the combined devices can slow the progression of heart failure, it could expand the market to this earlier stage group, which makes up about 70 percent of all heart failure patients.

Some analysts predict positive results will double the market for devices that combine CRT with defibrillators to about 500,000 patients, boosting company profits by shifting sales to the more expensive combination products.

Dr. Stephen Hammill, an electrophysiologist at the Mayo Clinic, said he expects positive results will likely shift sales to the more expensive combination devices from defibrillators, rather than increasing the number of implants.

"What I think we'll end up seeing is that when (a doctor) identifies a patient as a candidate for a defibrillator, it'll be more of a reflex to go straight to a CRT device," Hammill said. "The question is whether that will increase the total number of implants. I suspect it will primarily shift the proportion. There will be some increase, but mainly shifts."

He noted that Wall Street's predictions that defibrillator sales would rise sharply in the wake of a landmark 2004 study -- Sudden Cardiac Death in Heart Failure Trial or SCD-HeFT -- failed to materialize, even though it showed the devices reduced mortality in moderate to severe heart failure patients.

About a year after that study was published, defibrillator sales fell after a wave of product recalls tempered their use.