St. Jude says EU and U.S. approve defibrillator lead

NEW YORK (Reuters) - St. Jude Medical Inc on Thursday said U.S. and European regulators approved its Durata high-voltage lead, a wire used to carry electrical currents in implanted defibrillator devices used to control rapid heartbeats.

The company, which announced the approvals at the annual International Boston Atrial Fibrillation Symposium in Boston, said the flexible lead would offer greater use for doctors implanting it and greater durability.

St. Jude said the Durata lead and the company's equally thin Riata high-voltage leads are the smallest-diameter leads on the market -- and may thus be especially helpful for patients with restricted blood flow or patients who need multiple leads to be placed in a single vessel.

The company in November defended the safety and reliability of its Riata line of leads, in response to a Wall Street Journal report that said the leads, in rare instances, had poked holes in the hearts of some patients.

Concern about the safety of defibrillator leads arose in October when rival device maker Medtronic Inc suspended sales of its Sprint Fidelis line of leads because of what it termed a "small increased risk of fracture" that may have contributed to deaths of some patients.

Medtronic, which estimated about 268,000 Sprint Fidelis leads had been implanted worldwide, recommended that patients keep them in place but see their doctors to have their defibrillators reprogrammed to better monitor for the potential of a lead to fracture.

(Reporting by Ransdell Pierson; Editing by Steve Orlofsky)