MASSDEVICE ON CALL — The FDA’s updated its guidance on St. Jude Medical‘s (NYSE:STJ) recalled Riata defibrillator wires isn’t sitting well with all physicians.

"They’re saying, if the cables are extruded, you should pretty much just watch the patient," Brigham and Women’s chief cardiologist Laurence Epstein told the Wall Street Journal. "If the cables aren’t extruded, you should [still] pretty much just watch the patient."

Without updated guidance on how to care for patients who do have defective leads, the precaution may represent an increased cost without a payoff for patient health.

"It’s not clinical care, it’s research," Epstein told the Journal.

Last week the FDA ordered St. Jude to launch a 3-year post-market review of the recalled Riata and Riata ST leads, as well as for its QuickFlex LV CRT, QuickSite LV CRT, Riata ST Optim and Durata leads.

That was bad news for St. Jude, which has worked hard to distance its other leads, especially the Durata, from the high-profile Class I recall of the Riata leads in December 2011. The company recalled the devices, citing reports of high rates of "insulation abrasion," which occurs when the leads’ wires wear through their insulation. St. had Jude begun pulling the devices from shelves a year earlier over the same concerns.

The federal watchdog agency further advised that all patients with the recalled Riata leads undergo X-ray or other imaging to look for abnormalities in the wires that may lead to further problems.

"We believe that imaging recommendations at this time help health care providers manage health care of their patients," the FDA told the Journal.

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