St. Jude Medical Showcases New Product Offerings at Heart Rhythm Society Meeting in Denver
St. Jude Medical, Inc. (NYSE:STJ) today announced it will be showcasing 12 new product offerings at the Heart Rhythm Society’s 28th Annual Scientific Sessions in Denver. These products include industry or company “firsts,” representing every aspect of cardiac rhythm management technology:
— Merlin(TM).net Patient Care Network (PCN) remote monitoring – An Internet-based central repository where physicians can access patient device data through a secure Web site at any time, from anywhere Internet access is available. Patients can send data directly to their physician from the comfort of their own homes, offices or other locations using a portable transmitter. Additionally, Merlin.net PCN allows patient device data to be sent directly to the clinic’s or hospital’s electronic health records (EHR) system since the company has successfully completed IHE (Integrating the Healthcare Enterprise) testing guidelines. St. Jude Medical is the first cardiac rhythm management company to adhere to this set of EHR industry guidelines that enable healthcare information to be shared seamlessly across clinical settings.
— Current(TM) ICD and Promote(TM) CRT-D – St. Jude Medical’s premier ICD (implantable cardioverter defibrillator) and CRT-D (cardiac resynchronization therapy defibrillator) devices. The Current and Promote devices are the first to be built on the company’s new consolidated hardware and software platform to support ICDs, CRT-Ds and pacemakers. The new platform enhances functionality of St. Jude Medical products and offers great expansion potential for future advancements in therapy. The Current ICD and Promote CRT-D feature enhanced therapy and advanced diagnostics to help physicians care for individual patient needs.
The wireless versions of the Current ICD and Promote CRT-D devices (with radiofrequency telemetry) have just received European CE Mark approval. RF telemetry enables secure, remote communication between the implanted device and the programmers in a clinician’s office.
— Atlas(R) II+ HF CRT-D – The first U.S. heart failure (HF) device to offer St. Jude Medical’s proprietary AF Suppression(TM) algorithm. This device helps physicians manage HF patients who have or may develop atrial fibrillation (AF), which commonly occurs with heart failure.
— Zephyr(TM) pacemaker – St. Jude Medical’s first fully automatic pacemaker, which automatically performs all standard tests before patients enter the clinic for follow-up visits, thereby saving time.
— OptiSense(TM) lead – The first atrial lead to incorporate a unique tip design (with a shorter tip-to-ring spacing of 1.1 mm), offering more accurate sensing of the activity in the upper chamber of the heart (atrium). The lead design has been clinically proven to reduce Far R-Wave sensing (the sensing of unwanted signals from the lower chambers of the heart, the ventricles, by the atrial lead) resulting in a statistically significant decrease in inappropriate Automatic Mode Switch (AMS) episodes. (AMS is a feature that temporarily switches the pacing mode to protect against high ventricular rates due to the tracking of inappropriate high atrial rates.)
— Optim(TM) lead insulation – The industry’s first silicone-polyurethane co-polymer material created specifically for cardiac lead use and designed for long-term reliability, flexibility and handling.
— EnSite(TM) System Version 7 – EnSite 7 features field-scaling capabilities that allow the system to compensate for impedance variations so the clinician can create more accurate representations of the patient’s anatomy. It also includes new measurement tools which provide additional information for improved knowledge of the size and location of key cardiac structures.
— EnSite Fusion(TM) Registration Module – EnSite Fusion is the first and only registration tool that offers Dynamic Registration, allowing the clinician to optimize the fit of the navigation field to the scan model and view voltage, timing, and lesion data directly on the registered surface. (Not cleared for use in the United States.)
— The ACross(TM) Transseptal Access System – This tool combines all the components needed to perform a transseptal procedure into a single system with a proximal handle that controls the location and orientation of the needle, reducing procedural complexity. (Not cleared for use in the United States.)
— Reflexion Spiral(TM) Variable Radius Mapping Catheter – This new circular mapping catheter features the ComfortGrip handle for excellent control and handling. The Reflexion Spiral is also the only circular mapping catheter to have bi-directional steering and its diameter will adjust from 15 to 25 mm for exceptional versatility.
“We are pleased to bring so many innovative products to the premier annual meeting in our field,” said Michael J. Coyle, president of St. Jude Medical’s Cardiac Rhythm Management Division. “These products reflect our dedication to every aspect of cardiac electrophysiology, and are evidence of our commitment to providing individualized patient care and clinical efficiency.”
“Heart Rhythm Society 2007 is an opportunity for St. Jude Medical to collaborate with clinicians from around the world and develop leading technologies for the diagnosis and treatment of arrhythmias such as atrial fibrillation,” added Jane J. Song, president of St. Jude Medical’s Atrial Fibrillation Division. “We’re proud to introduce products that illustrate our continued dedication to developing curative therapies and techniques for such a prevalent disease.”
In addition to the array of products highlighted at the meeting, Paul A. Levine, M.D., FHRS, FACC, vice president of medical services for St. Jude Medical’s Cardiac Rhythm Management Division, received the prestigious Distinguished Teacher of the Year award from the Heart Rhythm Society (HRS). The award was presented during the opening plenary session of the Society’s annual meeting on May 9.
Dr. Levine received this recognition for his outstanding skills as a teacher in the area of cardiac electrophysiology and pacing. Since 1992, HRS has bestowed this award on physicians who have made significant contributions to the field of cardiac rhythm management and to the Society.
Heart Rhythm 2007 is the most comprehensive educational program for heart rhythm professionals, featuring over 200 educational sections and more than 130 innovative products and services. This year, the meeting opened with the AFib Summit, a two-day intensive summit on atrial fibrillation featuring world-renowned experts. The Heart Rhythm Society’s Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 11,000 people worldwide. For more information, please visit www.sjm.com.
Forward-Looking Statements
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 Company’s Annual Report on Form 10-K filed on February 28, 2007 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company’s Form 10-K). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.