Devices & Diagnostics

Lead recall puts the spotlight on Durata and St. Jude Medical’s Optim insulation

The Class I recall of the two Riata defibrillator leads from St. Jude Medical (NYSE:STJ) highlighted the issue of lead abrasion and insulation, but both those leads don’t have St. Jude Medical’s Optim technology. When lead abrasion occurs, it can cause the electrical conductors inside leads to come out of the insulation. Optim is a […]

The Class I recall of the two Riata defibrillator leads from St. Jude Medical (NYSE:STJ) highlighted the issue of lead abrasion and insulation, but both those leads don’t have St. Jude Medical’s Optim technology. When lead abrasion occurs, it can cause the electrical conductors inside leads to come out of the insulation.

Optim is a silicone polyurethane hybrid developed by the Minnesota medical device technology specifically to prevent lead abrasion, explained St. Jude spokeswoman Amy Jo Meyer, and is available in the Riata ST Optim and the Durata leads. More than 250,000 Riata ST Optim and Durata leads have been sold worldwide and were not part of the recall.

In the company’s October conference call with analysts before the Class I recall was announced, St. Jude CEO Daniel Starks provided rare detail about the issue of lead abrasion and the benefit of Optim technology.

… a key theme for us is that although the overall failure rates are low, we have long focused on insulation failure due to abrasion as a problem to solve in our efforts of continuous improvement in our lead technology. And so I’m not sure of the exact time line, it’s been 10 years or so that we’ve been invested and we’ve been developing a proprietary material that we call Optim, which we began to put into our lead line in 2006. Optim is 50 (times) more resistant to abrasion than silicone. You can no longer buy an ICD lead from St. Jude Medical unless it is protected from abrasion by Optim. That’s why at the end of last year, we completely discontinued offering to customers any ICD leads that were unprotected by Optim. Customers can only get the benefit of Optim protection against insulation failures and Optim protection against lead abrasion from St. Jude Medical.

In fact, in the November advisory letter that St. Jude sent to physicians about the issue of lead abrasion and the potential danger of Riata, the company noted that newer leads like Durata had Optim technology weren’t part of the recall.  Meyer, the St. Jude spokeswoman, reiterated that physicians are aware that the Durata leads have the Optim material to guard against lead abrasion.

That might well be true, but physicians don’t appear to be giving the Durata leads a pass, at least for now. The recently concluded Riata ICD Lead Summit (closed to reporters and analysts) showed “41 percent of physicians felt enough concern about the currently marketed Durata lead that they have elected not to implant this lead,” according to Dr. Edward Schloss who attended the summit and compiled a summary.

Schloss wrote that summit organizer Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute, emphasized that Durata leads need to be closely scrutinized. A second survey conducted after the session concluded that a higher percentage — 44 percent — said that they would not be implanting the Durata lead in the future.

Meanwhile, St. Jude Medical has issued a response that basically argues that the Riata ICD Summit did not have enough physicians in attendance — the company says only 55 were polled — to have any meaningful survey responses.

Still, it remains to be seen whether the Optim technology will be able to put the physicians’ fear about Durata at bay.