Two firms use small tech
in life-saving heart devices

By Jeff Karoub
Small Times Staff Writer

May 8, 2002 — One medical technology firm is launching its small-tech enabled heart device into the U.S. market, and another expects to quickly follow with its own version.

Guidant Corp. last week received approval from the U.S. Food and Drug Administration (FDA) to sell the Contak CD CRT-D, which combines treatment for heart failure with a defibrillator to regulate heartbeats.

Meanwhile, Medtronic Inc., the world’s largest medical device maker, received a recommendation for approval in March from an FDA advisory panel and awaits final clearance for its InSync ICD, which also treats heart failure and prevents life-threatening heart rhythms.

Both stopwatch-sized devices, already sold in Europe, contain MEMS accelerometers to monitor the heart’s activity level. The tiny machines work alongside microprocessors to deliver more electricity to keep the heart in rhythm when levels go above or below the person’s normal heart range.

The launches are coincidental — the companies clearly are competitors, and second-place Guidant isn’t bashful about boasting its Contak CD is the first device of its kind to be approved. Medtronic counters that its original InSync — minus the defibrillator — got the all clear for U.S. sales last August, making it the first firm to have a device for heart failure on the market in the states.

Still, the companies are at least in lockstep when it comes to serving an untapped, growing market.

“The companies recognize the need in the patient population,” said Annette Ruzicka, Guidant’s manager of corporate communications for cardiac rhythm management. “There’s a large, underserved patient population who did not have the option of device-based therapy. It’s not hard for both companies to recognize that and begin working on it.”

Ruzicka said it’s been a “happy couple of days” at Guidant since the FDA announcement, and with good reason. Being the first in the U.S. market to sell the dual devices gives it first crack at reaching those who suffer from heart failure and are at risk of sudden cardiac death. Guidant did not provide an estimated market size, but Medtronic said it’s at least 100,000 people and growing.

Guidant’s happiness also must have included a dash of relief. The Contak CD failed to get the backing of an FDA advisory panel, which reviewed the company’s research. Panel members expressed concern over Guidant’s study of the Contak CD, which missed its goal of cutting progression of heart failure by 25 percent.

Ruzicka said Guidant twice submitted additional data to the FDA to satisfy its concerns. The FDA said its approval was based on the results of two clinical studies.

The FDA said the Contak system improves some symptoms of heart failure, but the studies did not show whether the device ultimately affected patient survival. The federal agency is requiring Guidant to conduct a study of 1,000 patients during the next three years to determine the product’s effect on mortality and long-term safety.

Both companies see the market growing as the FDA reviews studies of heart patients. If more of the 5 million U.S. residents and 6.5 million Europeans suffering from heart failure are deemed eligible for a defibrillator, that could substantially boost sales of the Contak CD and InSync ICD.

“Heart failure is the only heart disease that is growing in prevalence,” said Scott Papillon, Medtronic’s senior public relations manager for cardiac rhythm management. “The technology and care have gotten so good (for most heart diseases), but for some reason heart failure is growing. It’s 5 million now and that will double in five years.”

Reaching that growing market will require the companies to focus less on competition and more on market development, said Glenn Reicin, a managing director and analyst with Morgan Stanley. Topping his list of challenges will be educating everybody — doctors, specialists, patients — about the devices’ benefits.

“It’s going to take a lot of muscle to develop this,” he said. “The fact that there are multiple players should be less of a concern — in fact, it should make the market grow even faster.”


Jeff Karoub at [email protected] or call 734-528-6291.

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