ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced products on display, sponsorship of several percutaneous coronary intervention (PCI) optimization symposia and reporting of results from an economic analysis during a late breaking trial session at the Paris Course on Revascularization (EuroPCR) 2011. The focus on clinical research and new product development reflects the company’s commitment to provide physicians with innovative solutions that demonstrate a tangible benefit to patients and society.
“With new technologies in PCI optimization and programs across all major structural heart categories, the St. Jude Medical cardiovascular leadership story has never been stronger. This strength is demonstrated at EuroPCR this year, where we remain the first and only company to offer a portfolio for interventional cardiologists that includes two innovative lesion assessment technologies - OCT and FFR,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division.
Late Breaking Trial
Data on potential cost savings in Europe for routine FFR use with the St. Jude Medical PressureWire™ will be presented by Professor Uwe Siebert, M.D., M.Sc., M.P.H., Sc.D., from the Health and Life Sciences University of Hall (Austria), who led the research project. The Late Breaking Trial is entitled, Cost-effectiveness and public health/budget - Impact of fractional flow reserve-guided PCI in multivessel patients in Europe - Analysis of the FAME study data.
The analysis, which was funded by an educational research grant from St. Jude Medical, was conducted to determine the incremental cost-effectiveness of FFR-guided vs. angiography-guided PCI in patients with multivessel coronary artery disease in different European health care systems from the societal perspective. Results from France, England, Italy, Switzerland, and Belgium will be revealed on Friday, May 20 at 9:40 a.m. in Room 342AB.
The results of the economic analysis of Germany revealed that an average of nearly 500 deaths and 1,300 heart attacks could be avoided over two years and approximately 14,000,000€ could be saved to the German healthcare system with routine FFR use over two years. They were announced this April at Deutsche Gesellschaft fur Kardiologie in Mannheim, Germany.
Products on Display
The company’s range of products and technologies for stent optimization, hemostasis management and structural heart will be on display in booths F06, F07 and F08 Tuesday, May 17 through Friday, May 20 including:
- PressureWire™ FFR Measurement System: St. Jude Medical pioneered the development of FFR measurements with its PressureWire technology, which indicates the severity of blood flow blockages in the coronary arteries. The PressureWire™ Aeris and PressureWire™ Certus provide a physiological measurement that helps physicians to better identify which specific lesion or lesions are responsible for a patient’s ischemia. The benefits of FFR were recognized in the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Guidelines with new recommendations for the treatment of coronary artery disease which support measuring FFR in a wide range of patients before performing PCI or recommending surgery.
- Optical Coherence Tomography (OCT): The C7-XR™ OCT intravascular imaging system aids physicians in the diagnosis and treatment of coronary artery disease. The OCT coronary imaging technology helps to optimize treatment with stents, and has about 10 times better image resolution and 20 times faster image capture over the current industry standard of Intravascular Ultrasound (IVUS). This efficient technology provides easy visualization, with high resolution images in less than five seconds.
- ILUMIEN™ System: This new technology is the world’s first system to integrate the functional and anatomical modalities of FFR and OCT into one platform, for enhanced diagnostics and improved cathlab efficiency. ILUMIEN enables OCT imaging with the third generation DragonFly™ OCT catheter, and FFR measurement through simple wireless connections which simplify set-up and measurement through the elimination of connecting cables. The combined technology offers PCI optimization that helps physicians determine if therapeutic intervention is necessary. The ILUMIEN System is pending European CE Mark approval.
- Wi-Box™: Available for the first time, this new technology enhances connectivity in the cathlab by providing physicians with a quick and easy FFR assessment at any time without any disruptions of the ongoing PCI procedure. The Wi-Box wireless technology enables an easy-to-use, uniform setup solution for all St. Jude Medical FFR platforms including RadiAnalyzer, RadiAnalyzer Xpress, and ILUMIEN (pending European CE Mark approval).
- Amplatzer™ PFO Occluder: The Amplatzer product line has become the standard of care for patients with structural heart defects. The Amplatzer PFO Occluder technology allows for simple and confident PFO closure using a minimally-invasive transcatheter procedure instead of surgery. The design fits all PFO anatomies and has demonstrated clinical success.
- Amplatzer™ Cardiac Plug: The Amplatzer Cardiac Plug provides an alternative therapy for reducing the risk of stroke in patients with atrial fibrillation. The unique design of the Amplatzer Cardiac Plug device provides secure placement and self-positioning for optimal occlusion at the orifice of the left atrial appendage.
- Other products: Amplatzer™ Vascular Plugs, Angio-Seal™ Vascular Closure Devices, FemoStop™ II Plus Compression Assist Device, and the RadiStop™ Compression Assist Device.
Virtual Reality Simulation Sessions
Physicians can learn more about physiological lesion assessment by simulating FFR and OCT cases using virtual reality technology. The simulator enables physicians to manipulate the PressureWire in order to practice an FFR measurement procedure in a human-size model from start to finish, including inducing hyperemia, post-stent assessment and PressureWire pullback. The simulator also allows physicians to practice the set-up, insertion and imaging steps required for high-resolution imaging of the coronary arteries. The virtual reality experience allows physicians to simulate different procedures and develop clinical skills in a controlled environment.
The virtual reality sessions will take place in the St. Jude Medical Advanced Technology Center at the EuroPCR Training Village on level 3 in room 8 from Tuesday, May 17 through Thursday, May 19.
Scientific Symposia and Lunch Sessions Sponsored by St. Jude Medical
St. Jude Medical will sponsor two symposia on stent optimization, including:
- Fractional Flow Reserve (FFR) to Simplify: Improving Outcomes in Multiple Patient Subsets, Tuesday May, 17 from 17:00 – 18:30 in room 342AB
- Optical Coherence Tomography (OCT) Lesion Assessment to Impact Decision Making in PCI, Wednesday, May 18 from 12:00 – 13:30 in room 352AB
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. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit 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 Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.