St. Jude Medical to Highlight Leadership in Lesion Assessment Technology at EuroPCR with Focus on FFR Platform

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the launch of a new virtual reality educational tool, sponsorship of several FFR-themed symposia and additional approvals of its PressureWire™ technology in Asia during the Paris Course on Revascularization (EuroPCR) 2010. The continued growth of the PressureWire platform and the recent announcement of plans to acquire LightLab Imaging, Inc., reflect the company’s commitment to providing physicians with solutions that enable them to make more accurate treatment decisions.

LightLab’s Optical Coherence Tomography (OCT) aids physicians in the diagnosis and treatment of coronary artery disease and complements the company’s leading PressureWire™ Fractional Flow Reserve (FFR) measurement technology, adding anatomical knowledge to the physiological information provided by FFR. While FFR can help physicians determine which lesions to stent, using OCT prior to stenting can help physicians select the proper stent size and then guide its deployment. Additionally, following deployment, OCT can help to assess the potential for future problems. The OCT coronary imaging technology has about 10 times better image resolution and 20 times faster image capture over the current industry standard of Intravascular Ultrasound (IVUS).

"St. Jude Medical will soon be the first company to offer a portfolio for interventional cardiologists that includes two of the top technologies featured at EuroPCR this year – OCT and FFR,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. "Once the acquisition is complete, we envision a future where OCT and FFR products will be seamlessly integrated into a single, easy-to-use lesion assessment solution. Taking into account our recently-released state-of-the-art Engage introducers, our recently approved Roll-X coronary guidewires, and our market-leading Angio-Seal and FemoStop products, St. Jude Medical is well-positioned to participate in every case, from skin-to-skin, with vascular access, diagnostic guidance, and hemostasis management.”

The company’s PressureWire technology, along with other products for interventional cardiologists, will be on display in booths F07 and F08 at the Palais des Congrès de Paris. Additionally, the LightLab Imaging Optical Coherence Tomography (OCT) technology will be on display in booth M12.

FFR Virtual Reality Simulation Sessions

Physicians can learn more about physiological lesion assessment by simulating FFR cases using virtual reality technology debuting for the first time at EuroPCR. 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 virtual reality sessions will take place in the St. Jude Medical Advanced Learning Center at the EuroPCR Training Village in room 341 in the Palais des Congrès on Tuesday, May 25 from 2:30 p.m. to 5:00 p.m., Wednesday, May 26 from 9:30 a.m. to 1:30 p.m. and 2:30 p.m. to 5:00 p.m., and also on Thursday, May 27 from 9:30 a.m. to 1:30 p.m.

Scientific Symposia Sponsored by St. Jude Medical and LightLab Imaging

St. Jude Medical will sponsor two continuing medical education symposia. "Treatment of patients with complex multivessel disease: Fractional flow reserve to improve and simplify lesion treatment” will take place on Wednesday, May 26 from 4:30 p.m. to 6:00 p.m. in the Maillot room, and "How fractional flow reserve can contribute to a successful treatment of complex arrhythmias” will take place on Thursday, May 27 from 5:00 p.m. to 6:30 p.m. in the Bagatelle room.

LightLab Imaging will sponsor a luncheon symposium on Wednesday, May 26 from 12:00 p.m. to 1:30 p.m. in room 251 entitled "Optical Coherence Tomography in the real world: Today’s clinical applications.”

Additional FFR Regulatory Approvals

The market-leading PressureWire™ Certus recently received regulatory approval in several key markets in Asia including Hong Kong, China, India and Taiwan. The technology has already been approved in the U.S., Europe, and Japan. It is the only guidewire on the market to provide a combined measurement of pressure and temperature, which enables calculations of FFR, Coronary Flow Reserve (CFR) and an Index of Microcirculatory Resistance (IMR).

The PressureWire Certus was the only FFR Measurement technology used in a landmark study called FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation), which compared FFR-guided treatment to treatment using standard angiography alone. The study demonstrated that patients whose treatment was guided by the PressureWire Certus prior to coronary stenting had a combined risk of death or myocardial infarction (heart attack) after two years that was 34 percent lower than those whose treatment was guided by angiography. There was also a difference of about $2,000, or 14 percent, per patient in health care costs between the two patient groups after one year.

About LightLab

LightLab Imaging, Inc., based in Westford MA, is the world’s leading manufacturer and marketer of Optical Coherence Tomography (OCT) for coronary imaging applications. LightLab’s OCT systems and imaging catheters are cleared for sale in 40 countries in Europe, Asia, the Middle East and North and South America. The company was founded in 1998 by the inventors of OCT, and has exclusive license to a broad range of OCT technologies and applications from MIT and other entities. The LightLab mission is to develop and distribute imaging technologies that improve patients’ wellbeing, enhance diagnostic medicine, improve outcomes, and reduce healthcare expenditures. With the ability to resolve real-time images to 15 micrometers, the LightLab Imaging OCT Imaging Systems offer physicians more precise information than ever before. For more information, visit www.lightlabimaging.com.

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.

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