St. Jude Medical (NYSE:STJ) pulled another of its defibrillator leads off the shelves over concerns that its conductors may poke through the wires’ insulated coating, the same issue that prompted the high-profile Riata lead recall.
The St. Paul, Minn.-based med-tech giant stopped selling its QuickSite and QuickFlex left-ventricular leads after confirming 39 cases of exposed conductors, an issue that occurs when the cable inside the lead wears through its silicone insulation.
Based on the reports, St. Jude expects the flaw to affect 3%-4% of the 171,000 QuickSite and QuickFlex leads sold worldwide. There have been no deaths, serious injuries or electrical dysfunctions reported in relation to the exposed conductors, the company noted.
The news sent STJ shares down 5.3% to $41.50 as of about 11:30 a.m.
Since the leads can operate normally once the conductors are exposed, the true rate of defect is likely higher than reported, but the rates are comparable to other CRT leads on the market, according to a press release.
Analysts at Leerink Swann weren’t overly worried about the new recall, as the QuickSite and QuickFlex leads only comprise about 10% of the company’s current left ventricular lead mix and a "very small proportion of overall revenues."
"Although a negative headline – and sounding painfully similar to the ongoing Riata "recall" – we think this issue will be manageable for STJ," analyst Rick Wise wrote in a note to investors. "This is clearly another blow to STJ’s lead reputation. But given that it is again concerning older-generation lead technology and the incidence rate has been very small (0.023%) with no patient adverse events reported, we currently do not anticipate any material financial or market share impact for STJ."
The affected leads are threaded through blood vessels into the lower left chamber of the heart to provide electrical stimulation to help it maintain normal rhythm, but are not responsible for providing life-sustaining pacing or life-saving defibrillation, according to St. Jude.
"If an LV lead were to fail, the other leads attached to the patient’s device would continue to deliver life-saving therapy," according to the release.
The news comes amid the company’s controversial Riata lead recall, a measure launched late last year which has since become something of a poster child for charges of faulty review at the FDA and inadequate post-market surveillance from device makers. Unlike the QuickFlex and QuickSite leads, Riata leads are responsible for life-saving and -sustaining therapy for patient with heart disease.
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.
It is not yet known whether this latest hit to St. Jude’s reputation will pose a problem for the company’s Durata leads.
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, but analysts’ reports from the American College of Cardiology conference last week noted 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."
To date there have been no reports of abrasion defects in St. Jude’s next-generation leads, including the QuickFlex Micro, Quartet and Durata, which make up about 90% of the company’s lead mix, Wise noted.
