Medical device giant St. Jude Medical (NYSE:STJ) landed an important win today after a research team released study results finding that the company’s Durata defibrillator leads proved safe and reliable in an independent review.
The Durata defibrillator leads, a newer model and alternative to St. Jude’s recalled Riata and Riata ST leads, demonstrated 99.4% freedom from all-cause mechanical failure at 5 years following implantation, researchers reported. St. Jude touted the study results in a late-breaking session at the Heart Rhythm Society meeting in Denver, Colo., today.
The study also found a 99.9% freedom from insulation abrasion, a key problem in the Riata and Riata ST leads which are coated in a different type of insulation than the Durata leads.
The study was conducted by the Population Health Institute, which analyzed data from ongoing prospective registries monitoring the performance of the Durata and Riata ST Optim leads, according to a press release. The researchers gathered data from 3 St. Jude-sponsored registries, which represent a combined store of more than 11,000 leads implanted at nearly 300 sites. Of all the leads analyzed, 38 showed mechanical failures, researchers reported.
"St. Jude Medical is proud to sponsor the largest actively monitored lead performance evaluation ever conducted for an ICD lead family," chief medical officer Dr. Mark Carlson said in prepared remarks. "We are pleased that PHRI’s independent analysis of our Optim-insulated lead registries continues to demonstrate the excellent safety and reliability of our Durata ICD leads."
The news is vital for St. Jude, which has been actively calming fears about the next-generation Durata leads ever since the company recalled the Riata and Riata ST and was forced to concede that the older leads’ revision rates were higher than previously reported.
News on Durata has previously had a big impact on St. Jude’s shares. In June 2012, 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.
STJ shares closed at $43.10 today, an increase of 1.6% on the day.