St. Jude Medical’s (NYSE:STJ) troubled Riata defibrillator lead was again the focus of attention today as a new study released at the American College of Cardiology conference in Chicago noted multiple issues with the wires that could lead to melted components and unnecessary shocks.
While the study put the recall back on the "front burner" among investors, doctors seemed optimistic that the issues plaguing Riata weren’t carried over to St. Jude’s Durata leads, analysts for Leerink Swann said in a note to investors today.
"Our sense from speaking to physicians is that though still cautious, some physicians now seem a bit more comfortable that Durata will likely not have the externalized cable issue that Riata has had," the analysts wrote.
A turnaround in physician attitudes is good new for St. Paul, Minn.-based St. Jude. At the end of a 1-day summit on the Riata recall held in January 44% of the 61 health care professionals in attendance said that they were concerned enough about Riata that they would not opt for the Durata lead in its stead.
STJ shares were up 0.8% to $43.84 as of about 1 p.m. today.
The latest study of 105 reports of failed wires found multiple issues along the length of the device that could contribute to a device malfunction, Bloomberg reported. A separate study found that 2.6% of patients with the Riata leads develop issues each year and that 19% of the patients have problems, according to the news site.
The FDA slapped the cardiology device maker with a Class I recall on the Riata leads in December 2011 after the company said they failed more frequently than previously reported. St. Jude recalled the Riata leads after receiving reports of high rates of "insulation abrasion," which occurs when the leads’ wires poke through their insulation. St. Jude started pulling the devices off the shelves a year earlier over the same concerns.
The risks of insulation abrasion aren’t fully understood, according to St. Jude, but the malfunction can cause an interruption in the cables’ ability to sense rhythm problems in the heart, possibly preventing needed shock therapy or causing unwanted shocks. But not all patients with externalized conductors experience electrical malfunction.
Two patients died and another suffered a serious injury when surgeons attempted to extract the exposed leads, St. Jude said in its recall notice.
The Durata device has features designed to to reduce tensions that may result in exposed wires, and features a more abrasion-resistant insulation, St. Jude spokeswoman Amy Jo Meyer told MassDevice in January.
"The Durata lead continues to demonstrate excellent performance by any measure," Meyer said. "We have ongoing prospective, actively monitored registries examining the performance of our Optim/Durata leads, representing 10,836 patients enrolled at 292 sites, with over 5 years and 24,000 patient-years of data."
St. Jude announced over the weekend that it enjoined the Population Health Research Institute to analyze data from 3 registries on the Riata and Durata leads, data representing over 10,000 leads implanted at 292 sites. The institute will designate a panel of independent physicians to review the collected data, representing more than 24,000 patient-years of information, according to a press release.