A single damaged version of St. Jude Medical Inc.'s Durata, a wire used to connect defibrillators to the heart, didn't have the same flaw that prompted the recall of an older device last year, the company said.
St. Jude has good news on new device
Company says its Durata defibrillator wire doesn't have the flaw that led to recall of its older Riata model.
By MICHELLE FAY CORTEZ and, Ryan Flinn
St. Jude obtained access to the defective device that was removed from a patient in April and reported last month to the Food and Drug Administration, the company said. Its analysis showed that the damage originated from the outside of the wire, known as a lead, not from a defect inside the insulated cable that could have frayed the lifesaving wire.
St. Jude stopped selling its older Riata wires in 2010 and recalled them a year later amid reports that the leads could break through the insulation in a defect known as "inside-out abrasion." Durata replaced Riata, and the new product's insulation coating was designed to prevent the complication. Little Canada-based St. Jude plunged 6 percent June 12 when details of a defective wire in a Durata device were posted in the FDA's Maude database.
"The damage to the Durata lead is consistent with external abrasion from contact with a calcified, or hardened, heart valve or possibly from lead-to-lead contact," St. Jude said in its statement. "External abrasion is a known cause of failure across all cardiac leads in the industry, which is different from the inside-out abrasion seen with externalized conductors observed in some Riata leads."
There have been no reports of an inside-out externalized Durata wire, said Amy Jo Meyer, a St. Jude spokeswoman.
St. Jude shares gained 2.6 percent to $37.90 on Friday, with most of the gain coming in the final half-hour of trading, after the company's statement was released.
St. Jude said it was able to identify a Durata device that matched the serial number, implant and event dates reported to the FDA and provided to the company. The device was removed from the patient at a Florida hospital, which allowed St. Jude to review the patient's records and X-rays and examine the device.
The patient previously had a different lead to connect a defibrillator to the heart. The older device had been deactivated and "capped," though it remained inside the patient. The Durata device and the older lead crossed each other at the same location where the frayed wires were reported in the Maude database, the company said. A rubbing of the two wires could have caused the damage, St. Jude said.
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MICHELLE FAY CORTEZ and, Ryan Flinn
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