St. Jude Medical Inc. (NYSE:STJ) sported some good news and some bad news, touting a regulatory win for its novel quadripolar pacing system while also warning doctors that its Riata defibrillator leads may pose a greater risk than previously reported.
The St. Paul, Minn.-based med-tech titan announced FDA clearance for the Unify Quadra cardiac resynchronization therapy defibrillator and Quartet left ventricular quadripolar pacing lead, calling it an industry first.
The system features four electrodes that can be used in 10 different pacing configurations, allowing physicians to implant the lead in the most stable way without compromising its effectiveness, according to a press release.
"This new system is designed to manage the dynamic challenges of heart failure," St. Jude medical cardiac rhythm management division president Dr. Eric Fain said in prepared remarks. "Based on the clinical experiences and publications to date, this innovative CRT system has the potential to redefine the standard of care in resynchronization therapy for heart failure patients around the world."
The Quadra system won Indian approval in September.
The systems were shipped to the company’s sales force immediately, according to the press release.
"We checked in with STJ and it emphasized that it expects to fully launch the Quadra system immediately," Leerink Swann analyst Rick Wise wrote in a note to investors. "Although we assume the product will carry a premium to current STJ leads, with only one month left in the quarter – and filled with holidays – we currently expect the impact of the launch to have a positive but somewhat limited 4Q sales impact."
Meanwhile, St. Jude’s Riata lead made headlines again as the company warned physicians (PDF) that the devices failed more frequently than previously reported.
St. Jude stopped selling Riata leads last year when it found a 0.47 percent rate of "insulation abrasion" after 9 years of use. The issue, which occurs when the lead wires poke through their insulation, can cause an interruption in the cables’ ability to sense rhythm problems in the heart and could prevent needed shock therapy or even cause unwanted shocks to a patient’s heart.
The company did not issue a recall at the time and sent a letter to doctors saying that a newer version of leads, which have a different coating, already represented 97 percent of the market.
An Irish team reported in September that the failure rate may be much higher than St. Jude’s estimates when it found that 15 percent of patients in a small study had confirmed cases of lead wires poking through their silicone rubber insulating cables and making contact with tissue at an average of about 4 years after implantation.
The company’s latest letter to physicians warns that Riata has a 0.63 percent failure rate. The figure is based on returns and complaints about the devices over the last 9 years, a method that St. Jude acknowledged is known to underestimate the true failure rate.
The growing concern has lead some physicians to reconsider using St. Jude’s products, according to Bloomberg. Sanford C. Berinstein & Co. analyst Derrick Sung reported that 20 out of 25 doctors he surveyed expressed medium to high levels of concern regarding the news of the Riata failures and that almost half thought the problem may also apply to other St. Jude leads.
The med-tech giant is conducing a prospective study on the long-term performance of its leads with enrollment beginning next month.