|View printer-friendly version|
|Results from Studies Evaluating High-Voltage Lead Performance Presented at Heart Rhythm Society's 29th Annual Scientific Sessions|
Four prospective studies with comprehensive record monitoring analyze 7,498 patients with Riata leads
ST. PAUL, Minn.--(BUSINESS WIRE)--May 15, 2008--St. Jude Medical, Inc. (NYSE:STJ) today announced that results were presented from the largest actively monitored, multi-site lead performance evaluation ever conducted for an ICD lead family. The data presented is from an analysis of four prospective studies, all with comprehensive data monitoring on the performance of the Riata(R) lead family. The analysis concluded that performance and reliability of Riata leads are excellent, based on data collected from more than 680 physicians at more than 370 sites.
The results were presented today at the Heart Rhythm Society's 29th Annual Scientific Sessions in San Francisco by the study's lead author, Andrew E. Epstein, M.D., of the University of Alabama at Birmingham.
The studies analyzed the experience of 7,498 patients who were implanted with Riata leads as part of their implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) systems. All sites participating in the four studies (ACT, OPTIMUM, RHYTHM and PAS; see below for a description of the studies) were monitored. To ensure the data were as accurate as possible, each patient's source records were individually reviewed to be certain that all lead-related complications (further sub-categorized as fracture, insulation damage, perforation or dislodgment) were reported.
The data showed that adverse event rates for all categories of lead-related complications were very low. Overall, the Riata leads' fracture rates were 0.09 percent (9 in 10,000), insulation damage rates were 0.13 percent (13 in 10,000, with no insulation failures exhibited in Riata leads utilizing Optim(R) insulation), perforation rates were 0.31 percent (31 in 10,000), and dislodgement rates were 0.88 percent (88 in 10,000). These adverse events rates are significantly lower than many previously reported rates in the medical literature on ICD leads.
The results are believed to be the largest and broadest analysis of lead-related complications ever to be presented, especially with complete data monitoring, and unlike reports of single-center experiences or case reports, should best represent real-world experience in a wide range of implanter's hands.
The results from these studies are particularly significant given the duration of follow-up, which was a median of 22 months for the four studies.
"St. Jude Medical is openly sharing this data so that physicians have better information upon which to make informed decisions in choosing a defibrillation lead, as well as information that may help to reduce the risks inherent in any medical procedure," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "We are committed to closely and continuously tracking the performance of our products so that physicians have reliable information that will lead to better care for their patients."
The rates of Riata lead-related adverse events are:
Lead Diameter Fixation Insulation Total Adverse Material Event ----------------- ---------------- ----------------- Description 8 F 7 F Active Passive Silicone Optim (n=6141) (n=1357) (n=6916) (n=582) (n=6405) (n=1093) ----------------------------- ---------------- ----------------- ----- Fracture (%) 0.11% 0.00% 0.10% 0.00% 0.11% 0.00% 0.09% ----------------------------- ---------------- ----------------- ----- Insulation Damage (%) 0.16% 0.00% 0.14% 0.00% 0.16% 0.00% 0.13% ----------------------------- ---------------- ----------------- ----- Perforation (%) 0.26% 0.52% 0.30% 0.34% 0.27% 0.55% 0.31% ----------------------------- ---------------- ----------------- ----- Dislodgement (%) 0.80% 1.25% 0.85% 1.20% 0.77% 1.56% 0.88% ----------------------------- ---------------- ----------------- -----
In November, 2007, St. Jude Medical shared Riata performance data from a subset of this patient group; those results were consistent with the data presented today but focused primarily on perforation of 7 F ICD leads (the smallest ICD leads available).The comprehensive study found that perforation rates of 7 F Riata leads were consistent with the low end of what has been reported on larger diameter leads in medical literature (0.6 to 5.2 percent). Small leads are particularly beneficial for some patients as they help physicians navigate through veins, allow for implants in small patients (including pediatric patients) and accommodate additional leads (if they are needed).
About the four studies ACT: Advancements in ICD Therapy Registry
Begun in November 2004, the ACT Registry is a prospective, multi-center, non-randomized, long-term data collection registry for patients receiving a market-released St. Jude Medical ICD system. This registry produces prospective, outcome-oriented data of all patients implanted with a St. Jude Medical ICD system, while also evaluating the utilization of advanced features in patients with current ICD indications.
A total of 4,571 patients at 314 clinical sites were implanted with a Riata lead by 361 physicians in the ACT Registry.
OPTIMUM: Optim Lead Insulation Material Registry
The OPTIMUM Registry began in August 2006; it is a prospective, multi-center, non-randomized, long-term data collection registry for any patient receiving a market-released St. Jude Medical Optim(TM) lead and a compatible market-released cardiac device (pacemaker, ICD or CRT). This Registry evaluates the chronic clinical performance of leads with Optim insulation material. (Optim insulation is a novel silicone-polyurethane copolymer hybrid which combines the durability of polyurethane with the flexibility of silicone.)
A total of 1,379 patients at 112 clinical sites were implanted with a Riata lead by 153 physicians in the OPTIMUM Registry.
RHYTHM and CRT-D Post Approval Study (PAS) RHYTHM IDE Study
The RHYTHM IDE study was initiated in July 2002; it was a prospective, multicenter study to demonstrate the safety and effectiveness of the St. Jude Medical cardiac resynchronization therapy devices (Epic(R) HF and Atlas(R) HF ICD systems, and the QuickSite(R) 1056K and QuickSite(R) 1056T left-heart lead models). All were conducted in an ICD indicated patient population with advanced heart failure (NYHA Classification III and IV) and cardiac dyssynchrony (LV ejection fraction less than or equal to 35%).
CRT-D System Post Approval Study (PAS)
The Post Approval Study began in November 2004 and is being performed in compliance with the Conditions for Approval from FDA. The purpose of this Post Approval study (PAS) is to characterize the chronic performance of the St. Jude Medical (SJM) Cardiac Resynchronization Therapy-Defibrillator (CRT-D system, e.g., Epic HF ICD, Atlas(R)+ HF ICD) and the St. Jude Medical biventricular pacing system (e.g., Frontier(R) and Frontier(R) II cardiac resynchronization pacemakers (CRT-Ps)), including the left-heart leads (e.g., Aescula(R) and QuickSite leads).
A total of 1,615 patients at 87 clinical sites were implanted with a Riata lead by 190 physicians in the RHYTHM IDE and CRT-D System Post Approval Studies combined.
About Heart Rhythm 2008
Heart Rhythm 2008 takes place May 14-17 at the Moscone Convention Center in San Francisco. The meeting is the most comprehensive educational event on heart rhythm disorders, offering 250 educational opportunities in multiple formats. The world's most renowned scientists and physicians will present a wide range of heart rhythm topics including advances in statins, cardiac resynchronization therapy, catheter ablation, cardiac pacing and heart failure and the latest technology, including state-of-the-art pacemakers and defibrillators. www.HRSonline.org
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 12,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K filed on February 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
CONTACT: St. Jude Medical, Inc.