Heart devices zapped by patient studies

Implantable cardiac therapy failed to pass muster in separate studies funded by device manufacturer St. Jude Medical.

Aaron Smith, CNNMoney.com staff writer

ORLANDO (CNNMoney.com) -- The cause of implantable heart defibrillators took a hit Tuesday when researchers reported the results of two studies that failed to reach their objectives.

The results, which were reported at the annual conference of the American Heart Association, missed their endpoints - the scientific goal for success.

Both studies focused on a type of implant called cardiac resynchronization therapy. The implants, which work like pacemakers, can shock the heart back into action when it stops beating and coordinate the rhythm of the ventricles of the heart.

The reports "are not helping the industry build the case that a broader patient population should be aggressively seeking treatment with these implantable devices," said Phil Nalbone, analyst for RBC Capital Markets.

Nalbone said the failed studies, funded by St. Jude Medical (Charts), which makes implantable defibrillators, are the latest step in the "continual chipping away at the market opportunity."

The first study, lead by researcher Dr. John Beshai, director of pacemaker services at the University of Chicago, failed to improve the ability to exercise for a specific population of heart failure patients. These patients met a specific type of measurement of electrical stimulation in the heart called QRS, and their heart-walls don't contract efficiently.

Beshai studied two groups of about 85 patients each, one using the sophisticated resynchronization function, and one without. He said he found no statistical difference between the two groups.

The second study focused on two groups of 197 heart failure patients. The one-year study showed that the resynchronization implants failed to prevent the most severe, or "permanent," type of atrial fibrillation, which is an abnormal heart rhythm.

The lead researcher in the study, Dr. Luigi Padeletti, cardiology professor at the Institute of Internal Medicine and Cardiology in Florence, Italy, said the instances of permanent atrial fibrillation were identical in both groups. He said they were also very low, at 3.3 percent.

"We couldn't draw any conclusions because so few people got atrial fibrillation," said Kathleen Janasz, spokesperson for St. Jude. But she said the study will be followed for another year, and that it would yield more results.

The market for implantable defibrillators has been in decline over the last two years and could use some good news. In one of the more recent black eyes to the industry, Medtronic (Charts, Fortune 500) in mid-October ceased production of the Sprint Fidelis lead, a wire connecting the defibrillator to the heart, after the product was linked to five deaths.

St. Jude competes with other implantable device makers like Boston Scientific (Charts, Fortune 500), Johnson & Johnson (Charts, Fortune 500) and Conor Medsystems. Top of page