May 2, 2012 — St. Jude Medical Inc. yesterday released its biannual product performance report (PPR) on its website, www.sjmprofessional.com. The PPR updates the performance of all the company’s cardiac rhythm management devices, including actively-monitored registry data that supports the safety and reliability of the current-generation Durata lead with Optim insulation. The report also provides a new, expanded analysis specifically addressing the performance of the company’s high-voltage leads.
The April 2012 PPR provides an update on the combined Optim lead registries enrolling either Durata or Riata ST Optim leads, which is comprised of the OPTIMUM registry, the SCORE registry and the SJ4 Post Approval Study. These post-market evaluations are prospective, outcome-oriented and actively monitored. A total of 10,950 Optim-insulated defibrillation leads are enrolled in these studies at 292 sites. These leads have been followed for up to more than five years with a total of 27,477 patient-years of follow-up.
The performance results for the combined Optim lead registries, for data collected through Feb. 29, 2012, include:
- No instances of externalized conductors caused by inside-out abrasion;
- 99.96 percent rate of freedom from all-cause insulation abrasion; and
- 99.84 percent rate of freedom from all-cause mechanical failure.
“The performance data from the combined registries confirm that the Durata lead performs, at five years, as well as or better than other ICD [implantable cardioverter defibrillator] leads on the market,” said Charles Love, professor of medicine and director of cardiac rhythm device services, Wexner Medical Center at The Ohio State University. “These data demonstrate that the changes in design and addition of Optim insulation material on St. Jude Medical's current-generation leads have significantly reduced the abrasion-related issues associated with Riata silicone-only leads.”
St. Jude Medical also announced the largest of the three registries, the OPTIMUM registry, will be enhanced to further extend the study’s follow-up duration to follow patients indefinitely. In addition, the registry protocol is currently in the process of implementing plans to collect fluoroscopic images of the leads going forward. This expanded protocol will provide additional insight into the performance of the company’s current-generation leads.
“Our biannual product performance report is part of our commitment to providing physicians complete and accurate information so they can make decisions about how to best treat their patients,” said Eric S. Fain, M.D., president of the St. Jude Medical cardiac rhythm management division. “The combined registry data on our Optim leads represent the most robust post-market surveillance monitoring system in the ICD industry, which will also be independently verified by a third-party research institution.”
Data in the active registries are collected on case report forms at each scheduled and unscheduled patient visit with additional information documented for any adverse event. A dedicated field monitoring organization ensures that the data from the clinical site are accurately and completely submitted. Because of the size and scope of the actively monitored registries, they represent the true commercial experience with the company’s current-generation high-voltage leads.
In March, St. Jude Medical announced that at the company’s request, the Population Health Research Institute (PHRI), an academic health science research institute affiliated with McMasters University, Hamilton, Ontario, has agreed to analyze data from the combined Optim lead registries. The analysis will be entirely under the control of PHRI, who will complete a review of the raw data and report their findings independent of the company.
Update on Riata Lead Evaluation Study
St. Jude Medical is also conducting the prospective Riata Lead Evaluation Study, which will now enroll approximately 700 patients from the United States, Canada and Japan to provide information that will assist clinicians in the management of patients with Riata leads. The company stopped selling the silicone-only insulated leads in 2010 due to higher rates of abrasion than current-generation products. The study began in December 2011 and continues to enroll patients; the study has already enrolled more than 600 patients and fluoroscopic images are currently being adjudicated by independent physicians. The company expects to have the initial results reporting on the incidence of externalized conductors compiled and communicated before the end of June 2012. The study will continue to follow patients to evaluate the performance of leads that have externalized conductors over the next two years to further inform patient management.
For more information: www.sjm.com