St. Jude Medical ($SJM) is advising doctors that its Riata leads, which connect implanted defibrillators to the heart, have a higher rate of insulation failures than initially reported. In a letter posted to its website, St. Jude informs doctors that of the more than 227,000 Riata and Riata ST silicone leads sold worldwide over the past 9 years, the incidence rate is estimated to be 0.63%, not the 0.47% communicated in December 2010, when the company stopped selling the product.
St. Jude indicated that the removal of a Riata lead with externalized conductors had resulted in two patient deaths and one serious injury. One additional death and injury in patients with externalized conductors were reported, but were deemed unrelated to the insulation issue.
The company is conducting a prospective study to evaluate the incidence and long-term performance of leads with externalized conductors that do not exhibit electrical abnormalities. It anticipates beginning enrollment before the end of the year.
The problems with Riata could cause concern among investors, who may fear that doctors will reduce their use of other currently available St. Jude leads, said Jefferies analyst Raj Denhoy, as quoted by Reuters. Even though the increase in the number of Riata problems was small, the actual rate of incidents associated with the lead is probably higher, he added. "My sense is that if you talk to clinicians, most would tell you the number is actually higher than that," Denhoy said.
ALSO: St. Jude Medical has received the FDA's nod for its Unify Quadra cardiac resynchronization therapy defibrillator and Quartet left ventricular quadripolar pacing lead. The company will begin shipping the products to its sales force to begin providing to customers immediately. St. Jude's release