Ernest Lau, a cardiologist at the Royal Victoria Hospital in Belfast, Ireland, was one of the first doctors to identify a defect in St. Jude Medical Inc.’s Riata that led to its recall in 2011. Now Lau is telling colleagues it’s time to embrace the company’s updated device.
Riata, a wire that connects a life-saving defibrillator to the heart, could break out of its protective coating, putting patients at risk for inappropriate shocks or leaving them untreated when a shock was needed. Lau noted the flaw in 2006, and subsequent tests to patients found the problem occurred in 15 percent. St. Jude pulled the device from the market in 2010, with U.S. regulators calling it a recall the next year.
The potential risk led Lau and other doctors who implant the devices to avoid Durata, a newer product from St. Paul, Minnesota-based St. Jude that has a similar design and is coated with a stronger insulation to prevent the problem. The addition of that coating, known as Optim, compresses the tubing and makes similar breaches unlikely, Lau said. Further avoiding St. Jude’s leads may chill future innovation, he said.
“There’s a huge danger of people overreacting,” Lau said. “Whenever you bring a new product to the market, you take a quantified risk. If there is a genuine problem we all have to react to protect the patients. Acting out of irrational fear, if you keep doing that, we’ll have stagnation. If we stick with the status quo for eternity, then we’ll never have innovation.”
There have been reports about isolated complications related to Durata, with articles in medical journals appearing in March and June. Larger database reviews, however, have uncovered few issues with the device, and suggest it is working as well as rival products from Medtronic Inc. and Boston Scientific Corp.
St. Jude rose 1.7 percent to $43.99 at the close in New York. The company has gained 13 percent in the past 12 months.
Lau, an electrophysiologist who has been working for the past two years on understanding the mechanisms that caused Riata to malfunction, plans to publish his findings next week in the journal Pace, according to Larry Biegelsen, an analyst at Wells Fargo in New York. Based on that work, Lau said he doesn’t expect to see similar problems with Durata.
“Fundamentally, the Durata and Riata leads are very different,” Lau said in a telephone interview. “Because I believe I understand the mechanism now, and I’ve done some experimental work to test the Durata lead, it doesn’t have the capacity to develop externalization.”
The newer leads may short-circuit, though the problem outlined by Robert Hauser of the Minneapolis Heart Institute isn’t common, Lau said. There are ways to implant the device that can further reduce the risk, he said.
“It’s unlikely that Durata will have internal shorting as a frequent problem,” Lau said. “I’ve been using the Durata lead quite a lot and I haven’t seen any internal shorting at all. With the Riata lead, it was quite common.”