St. Jude Medical Inc.’s Durata lead, the wire used to connect life-saving defibrillators to the heart, proved safe and reliable in an independent review that should ease concerns about its use, researchers said.
Questions lingered about the Durata leads since an older version known as Riata was pulled off the market in 2010 because the internal wires could break through the protective coating. While no evidence showed a similar problem with Durata, which has stronger insulation, some doctors have shied away from using it. Medtronic Inc. and Boston Scientific Corp. have increased their share of the $6 billion market, according to data compiled by Bloomberg.
The review of more than 11,000 Durata wires presented at the Heart Rhythm Society meeting in Denver today found mechanical failures in just 38 cases. There were no problems seen with wires coming out of their casing, said John Cairns, a cardiologist at the University of British Columbia. The results bolster two smaller studies presented yesterday that found the leads performed as well as the current market leaders.
“It looks very reassuring for someone who has one of these leads,” Cairns said in a telephone interview. “Their chance of having a mechanical failure by five years is about six in 1,000, and most are picked up by routine monitoring,” he said.
It’s too soon to know whether the risks will increase after six or seven years, Cairns said. At the five-year mark, however, the risk with Durata is significantly lower than what was seen with the older Riata devices, he said.
St. Jude, based in St. Paul, Minnesota, asked the Population Health Research Institute at Hamilton Health Sciences and McMaster University in Ontario to conduct an independent review of three databases enrolling patients with Durata or newer Riata ST devices coated with the new Optim insulation. The researchers examined every reported failure with the devices for patients in the registries through February 2013.