April 16, 2012 / 8:15 PM / in 6 years

Medtronic to boost safety monitoring of devices

WASHINGTON (Reuters) - Medtronic Inc plans to ramp up monitoring of its medical devices after they are implanted in order to catch potential safety problems earlier, as the industry wrestles with some headline-grabbing recalls.

Medtronic Chief Executive Omar Ishrak said it was the responsibility of companies to monitor devices for safety problems after they are approved rather than relying on irregular reports from doctors or patients, as they do now.

He also said registries, or nationwide databases, that some groups have proposed to keep track of patients with devices, would not be enough to collect the kind of comprehensive data needed to catch safety problems.

“We need improvements in device surveillance,” he told Reuters on Monday. “The FDA alone does not have the infrastructure... so companies have to play a leading role in this.”

Consumer groups have urged the U.S. Food and Drug Administration to impose more rigorous testing of devices before they are approved to avoid safety failures, including issues with metal-on-metal hip implants and surgical mesh.

In the latest high-profile setback, Medtronic rival St. Jude Medical Inc was forced to halt sales of some defibrillator leads, or wires that carry electricity from defibrillators to the heart, because of concerns their insulation could wear away.

An article in the medical journal HeartRhythm had also linked failures of an older version of St. Jude’s leads to patient deaths, denting the company’s shares.

Medtronic, the world’s largest stand-alone medical device maker, came under fire last year after allegations that researchers hid serious complications with its spine product Infuse during clinical trials.

Ishrak said Medtronic plans to invest “heavily” in keeping track of patients’ health after they get a new device, and doing regular analysis of the data to spot any worrying trends.

“You have to address these issues as early as possible,” he said, adding that pre-market testing would never be able to catch every possible problem.

Ishrak declined to comment on what impact St. Jude’s woes could have on Medtronic’s sales of heart defibrillators, or how it might affect the overall market.

“We’re focused on winning with what we have,” he said.

In 2010, Medtronic had 46 percent of the multi-billion-dollar market for implantable heart defibrillators. St. Jude had 29 percent of the market and Boston Scientific Corp had a 25 percent share.

Reporting by Anna Yukhananov; Editing by Tim Dobbyn

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