Corrected November 9, 2012, at 11:30 a.m.
In continuing efforts to defend its Riata ST Optim and Durata leads from the effects of a controversial recall, St. Jude Medical (NYSE:STJ) released independent analyses of its ongoing registry data touting very low failure rates for the newer devices, especially in regard to potential lead abrasion.*
The news may serve to deflect some of the ongoing concerns that arose after the device in December 2010 recalled the Riata leads over concerns that the ICD leads failed more often than expected and had a heightened likelihood of poking through their silicon insulation, a defect that could prevent needed shock therapy or even cause unwanted shocks to a patient’s heart.
Newly released findings, which represent roughly 5.5 years of registry data, found a 0.06% all-cause abrasion rate and a 0.31% all-cause mechanical failure rate for the Riata ST Optim and Durata leads, which feature an Optim insulated coating that St. Jude has said is more durable than the silicon used in the older generation Riata lead.
Those figures, which represent nearly 11,000 leads implanted at more than 290 sites, are significantly lower than the failure rates that started the Riata lead foofaraw. The Riata affair began in December 2010 when St. Jude pulled the devices off of shelves without issuing a recall, reporting a a 0.47% rate of "insulation abrasion" over 9 years of use.
"Abrasion of silicone defibrillation leads is acknowledged within the clinical community as a well known clinical risk and is well documented in the literature as the number one cause of lead failure across the industry with reported failure rates ranging from 3 to 10 percent," St. Jude said at the time.
In September 2011 a small Irish study reported a 15% abrasion rate for the Riata leads at an average of about 4 years following implantation, setting off a firestorm of controversy and medtech industry in-fighting.
Just months later St. Jude conceded that its Riata leads failed more frequently that the company had previously reported, now recognizing a 0.63% failure rate over 9 years. By the end of 2011 the medical device maker recalled the Riata leads, a move the FDA slapped with Class I recall status.
St. Jude has been busy ever since calming fears about the next-generation Durata and Riata ST Optim leads. The company hosted several events at the Heart Rhythm Society meeting in Boston earlier this year, distancing the Durata leads from their troubled forebears.
In a special, highly attended talk entitled "Should we trust Durata?" Dr. Chuck Love told listeners that "Durata is 85% different from Riata," noting that the Durata device has a more robust coating than the Riata’s silicone insulation.
Wall Street investors are keeping their eyes peeled for any sign of a problem with the Durata leads. In June, a single report (later debunked) of a Durata lead failure similar to the kind that sank the Riata sent STJ shares plunging 6% in a single day.
Meanwhile, the newer leads have had to fend off an entirely different type of dilemma.
Last month the Scottish firm that makes the insulation for the Durata leads accused St. Jude of breaching their contract, filing a filed a "rectification notice" against the St. Paul-based medical device company, accusing it of "material breaches" of their deal.
The medical device maker highlighted the results, which were prepared independently by the academic Population Health Research Institute, in its 2012 St. Jude Medical Product Performance Report, which was released on the company’s website last night.
This week St. Jude successfully sued AorTech and won an injunction against the termination of their supply deal.
*Due to a reporter’s error, this story mistakenly referred to the Riata ST, rather than the Riata ST Optim lead.
