St. Jude Medical's cardiovascular healthcare portfolio to be presented at TCT meeting

Sep 23 2009

St. Jude Medical, Inc. (NYSE:STJ) today announced it will display products and technologies from the company’s portfolio of solutions for cardiovascular healthcare professionals at the 21^st annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco. The featured products reflect the company’s continued commitment to developing comprehensive, high-performance solutions which advance the practice of interventional cardiology by improving efficiencies and giving physicians more control.

The company’s latest products and technologies for access, intervention, hemostasis management, cardiac rhythm management, and valve replacement will be demonstrated and on display on Sept. 23 and Sept. 24 from 9 a.m. to 5 p.m. and Sept. 25 from 9 a.m. to 2 p.m. at the St. Jude Medical booth (#1704) including:

Access:

St. Jude Medical access products are designed to provide simple, consistent and repeatable methods that help physicians gain and maintain arterial access during diagnostic and interventional procedures. High-quality vascular access is a critical component of any procedure’s success, and St. Jude Medical is dedicated to providing products that make the entire procedure more effective and efficient from access to closure.

• Engage™ Family of Introducers: This new product line was designed to provide physicians with reliable access and set the stage for closure using Angio-Seal™ and other St. Jude Medical closure devices. These introducers help to ensure smoother access by reducing the amount of required insertion force, helping to maintain hemostasis and allowing for easier device manipulation. The Engage™ Introducer is used for femoral access, in which physicians access the patient’s heart through the femoral artery located near the groin; this portfolio includes 22 model configurations of varying sizes to accommodate most patients. The Engage TR™ Introducer portfolio includes 18 model configurations and expands the company’s product offering to include introducers used for radial access, in which physicians access the patient’s heart through the radial artery in the arm. The Engage Introducers have received Conformité Européene (CE Mark) approval; pending 510(k), not available for sales within the U.S.
• Other Access Products on Display: Strada™ Carotid Guiding Sheath, Hydrosteer™ Guidewire, TigerWire™ Steerable Guidewire, Venture™ Wire Control Catheter, and Fast-Cath™ Hemostasis Introducers.

Intervention:

St. Jude Medical now offers PressureWire™ technology, adding an interventional product to its portfolio of leading cardiovascular technologies. The landmark FAME study, published in the New England Journal of Medicine in January 2009, demonstrated superior clinical outcomes for FFR-guided (fractional flow reserve) therapy using St. Jude Medical PressureWire products compared to those whose treatment was guided only by angiography. Notably, there was a statistically significant difference of 28% in Major Adverse Cardiac Events (MACE) such as death, myocardial infarction and repeat revascularization; in addition to better patient outcomes, material costs of the procedure were also reduced by about 11%.

The two-year results from the FAME study will be presented at TCT on Wednesday, Sept. 23 at 12:15 p.m. during the late-breaking session: “Two-Year Follow-up from a Prospective Randomized Trial of FFR-Guided vs. Angiography-Guided PCI in Patients with Multi-vessel Coronary Artery Disease.”

• PressureWire™ Aeris Wireless FFR Measurement System: This first-of-its-kind wireless FFR measuring system requires no additional equipment or cabling and gives physicians instant access to patient data. The Mac-Lab® Hemodynamic Recording System, developed by GE, immediately displays, measures and archives the patient’s FFR data using the PressureWire Aeris technology, enabling interventional cardiologists to pinpoint which specific lesion or lesions are responsible for a patient’s ischemia, helping to guide coronary interventions. The PressureWire Aeris has received 510(k) clearance from the FDA and CE Mark approval.
• PressureWire™ Certus FFR Measurement System: The PressureWire Certus device also is used to identify the functional severity of coronary stenosis, and was the only FFR measurement system used in the recent FAME study, which indicated superior clinical and cost-effectiveness outcomes for the FFR-guided patient group versus angiography alone. The PressureWire Certus has received 510(k) clearance from the FDA, CE Mark approval, and Japanese Ministry of Health, Labour and Welfare (MHLW) approval.
• Other Product on Display: Proxis™ Embolic Protection System.

Hemostasis Management:

From active vascular closure to compression-assist devices, St. Jude Medical has the most complete portfolio of products to aid physicians in achieving hemostasis following cardiovascular interventions. St. Jude Medical presents the eighth generation of the successful Angio-Seal product family with the most advanced design yet – the Angio-Seal™ Evolution™. With the addition of two compression-assist devices following the acquisition of Radi Medical Systems, RadiStop™ Compression-Assist Device and FemoStop™ Gold Compression-Assist Device, the company can now offer physicians a full spectrum of closure technology to aid hemostasis.

• Angio-Seal™ Evolution™ Vascular Closure Device: The new Angio-Seal Evolution device incorporates its repeatedly proven active closure system using a fully bioabsorbable anchor with a new, simpler system for deployment. This next-generation product from the industry-leading Angio-Seal product line was designed to reduce the number of necessary steps for closure and to assist physicians in overcoming procedural variables. The need to manually compact the collagen was eliminated, and only one suture cut is required. The Angio-Seal Evolution has received FDA and CE Mark approval.
• Other Products on Display: Angio-Seal™ VIP, RadiStop Compression-Assist Device and FemoStop Gold Compression-Assist Device.

Cardiac Rhythm Management (CRM) and Valves:

St. Jude Medical is committed to developing smarter, more active products which reduce patient risk and improve physician control during procedures. The company’s comprehensive portfolio of wireless CRM technologies is changing the way that physicians view connectivity and more efficiently manage their patients. Additionally, St. Jude Medical is continuing its efforts to develop additional products and technologies for patients suffering from debilitating cardiac diseases with durable tissue and mechanical valves.

• Accent™ RF and Anthem™ RF Pacemakers: The market’s first completely wireless pacemakers from implant through follow-up, the Accent RF pacemaker and Anthem RF cardiac resynchronization therapy pacemaker (CRT-P) enable physicians to wirelessly program the devices, transmit comprehensive diagnostic data and be alerted to important changes in the device or with the patient’s condition through the Merlin.net™ PCN (Patient Care Network). The Accent RF and Anthem RF pacemakers have received FDA and CE Mark approval.
• Merlin.net® Patient Care Network: A secure, Internet-based remote care system for patients with implanted medical devices that gathers and stores data from the implant procedure, in-clinic follow-up visits and from remote transmissions sent from a patient’s home. The recently launched version 4.0 of Merlin.net PCN provides an additional feature called DirectTrend™ Viewer, which graphically displays patient trends and disease progression. This allows physicians to more effectively and efficiently manage patients through interactive views of patient data over time. Version 4.0 of the Merlin.net PCN has received FDA and CE Mark approval.
• Epic™ Stented Tissue Valve: Incorporating Linx™ anticalcification technology, this valve was designed to be durable and better resist calcification and mechanical stress. The Epic Stented Tissue Valve has received FDA and CE Mark approval.
• Other Products on Display: SJM Confirm® Implantable Cardiac Monitor, Zephyr® Pacemaker, Microny® Pacemaker and Biocor™ Stented Tissue Valve.

For additional information about the products displayed in the St. Jude Medical booth, please visit SJMprofessional.com.

In addition, the results from the two-year follow-up of the landmark FAME study is being presented as a late-breaking trial at TCT on Wednesday, Sept. 23 at 12:15 p.m. Results from the study, which was sponsored by St. Jude Medical, will reveal updated information about MACE, procedural time and material costs, among other topics. For additional information about the FAME study visit FAMEstudy.com.

St. Jude Medical will also host a breakfast symposium titled “Implementing Evolving Tools for Percutaneous Coronary Interventions: Access, Lesion Assessment, Closure” on Thursday, Sept. 24 from 6:30 a.m. to 8:00 a.m. Dr. Robert J. Applegate, Medical Director of the Cardiac Catheterization Laboratory at Wake Forest University Baptist Medical Center, will be speaking on Integrating Access and Vascular Closure and Dr. Augusto Pichard, Director of the Catheterization Laboratory at Washington Hospital Center, will be speaking on implementing an FFR program at a high-volume PCI center.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. The 2009 Conference takes place September 21-25 at The Moscone Center in San Francisco, CA. TCT is the world's largest educational meeting specializing in interventional cardiovascular medicine. For more than 20 years, TCT has been the center of cutting-edge educational content. This year's program will reflect the advances and changes in the field while maintaining a long-standing commitment to TCT's core values: focus on therapy innovation, trust in evidence-based medicine and dedication to putting patients first.