St Jude Phases Out Defibrillator Cables Amid Insulation Issue

St. Jude Medical Inc. (STJ) is taking a group of defibrillator cables off the market amid signs an older insulating material is more vulnerable to problems that could cause malfunctions, which has long been an industry challenge.

The St. Paul, Minn., device maker discussed the issue in a letter to doctors dated Wednesday while saying that cables with a newer coating have a lower rate of issues. These newer cables have already all but replaced the older ones on the market, representing 97% of sales, St. Jude said.

The company recommended doctors continue regular monitoring of patients with the "Riata" brand cables at issue--of which 227,000 have been sold world-wide--while doing some specific testing if they suspect lead failures. A company spokeswoman said the Food and Drug Administration doesn't view this as a recall at this time; an FDA spokeswoman was unable to immediately comment on the matter Thursday.

The company does not recommend that doctors preemptively remove these cables, which can be a complicated procedure. St. Jude said its medical advisory board agrees with these recommendations.

At issue are the "Riata and Riata ST" family of leads, or cables that connect defibrillators to the heart, with silicone as an outer insulation material. St. Jude's letter to doctors said there was a 0.47% rate of "insulation abrasion" over nine years of use in such leads, and that a planned phase-out will be completed by the end of this year. This type of insulation compromise can interrupt the cables' ability to sense rhythm problems in the heart, which can cause defibrillators to fire shocks when they aren't needed or to not provide shocks when they are needed, both of which are potentially life-threatening problems.

St. Jude noted in the letter that underreporting of complications with defibrillator leads "is well acknowledged throughout the industry," and that the statistics should be taken in that context. St. Jude competes in the roughly $12 billion market for heart-rhythm devices with Medtronic Inc. (MDT) and Boston Scientific Corp. (BSX).

Arnold Greenspon, who directs the electrophysiology lab at Thomas Jefferson Hospital in Philadelphia, said he didn't consider this a major issue given the rate of problems cited. He said a St. Jude representative notified him about the matter on Wednesday.

The company told doctors that newer leads with a type of insulation it calls "Optim"--sold with Riata ST Optim and Durata leads--have demonstrated a better than 80% reduction in "abrasion-related observations" after 44 months compared with silicone leads. The Optim insulation involves both silicone and polyurethane.

"The insulation is the weakest link" for defibrillator leads, said Haris Haqqani, an electrophysiologist at the Hospital of the University of Pennsylvania, also in Philadelphia. He said the industry at large has been working to get away from coatings that were developed for other applications in favor of materials specifically designed to handle the bending, strain and other challenges leads face inside the body.

St. Jude's Riata-brand leads have been in the news before. There were some concerns among doctors three years ago, shortly after a Medtronic recall of fracture-prone "Sprint Fidelis" leads, that Riata leads were poking holes in hearts. St. Jude at the time said its monitoring didn't show signs these cables were linked to more perforation problems than any other defibrillator leads.

St. Jude shares were recently up 0.6% to $41.97.

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com

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