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St. Jude Medical Announces Launch of OPTIS Integrated System

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St. Jude Medical, Inc. (NYSE:STJ) , a global medical device company, today announced the company has secured CE Mark and FDA clearance for the new OPTISTM Integrated System. The system is a departure from traditional, mobile cart-based diagnostic tools and advances percutaneous coronary intervention (PCI) optimization via direct installation into a hospital’s cardiac catheterization laboratory, fully integrating optical coherence tomography (OCT) and fractional flow reserve (FFR) into PCI workflow.

The approval of the OPTIS Integrated system marks the launch of the world’s first PCI optimization system to offer OCT and angiography co-registration, which supports procedural decisions by providing high-resolution, 3-D OCT views of coronary anatomy while mapping the exact location of physician’s current view via angiogram. The OPTIS Integrated system also integrates St. Jude Medical PressureWireTM fractional flow reserve (FFR) measurement technology to provide access to critical hemodynamic information during PCI.

The system will be on display for the first time during Transcatheter Cardiovascular Therapeutics (TCT) 2014, in Washington, D.C.

“As the interventional cardiology landscape has shifted to the treatment of more complex patients, intravascular imaging and fractional flow reserve have emerged as critical tools for enabling physicians to make more informed treatment decisions during PCI,” said Dr. Gregg Stone, interventional cardiologist and director of cardiovascular research and education at Columbia Presbyterian Medical Center and the Cardiovascular Research Foundation. “By integrating these tools directly into cath lab infrastructure, we can enhance access to technology and have them readily available during PCI procedures.”

Percutaneous coronary intervention, or coronary angioplasty, is a non-surgical procedure designed to eliminate coronary blood flow blockages and restore blood flow to the heart. Traditionally, physicians have relied on angiography or intravascular ultrasound to guide PCI. St. Jude Medical originally combined OCT and FFR technology in the ILUMIENTM OPTIS and OPTIS Integrated systems to enable a more detailed, physiological and anatomical analysis of blood flow blockages inside the coronary arteries.

OPTIS Integrated advances PCI optimization technology further by offering a side-by-side view of OCT and angiography via a co-registration to “map” culprit lesions and provide the visual data necessary to guide stent selection and deployment. In addition, FFR technology allows physicians to assess the severity of blood flow blockages. Direct tableside controls allow physicians to directly drive system operations while a new user interface prioritizes image display for increased visibility and operation. Stent planning tools enable enhanced precision in determining optimal stent sizing and placement.

“PCI as a procedure has been around for decades, but only recently has the procedure been optimized by new diagnostic tools that can improve clinical outcomes,” Dr. Giulio Guagliumi, an interventional cardiologist with Ospedale Papa Giovanni XXIII in Bergamo, Italy. “On demand FFR and OCT can support clinical decision making by providing highly-detailed intracoronary arterial views, which improves PCI, especially in complex cases. Furthermore, the resolution of OCT over intravascular ultrasound can be imperative in reducing challenges such as stent fracture and edge dissection.”

“We developed the OPTIS Integrated system in response to physicians who wanted a more integrated system that combined angiography, the current standard of care for intravascular imaging, with diagnostic technology that adds clinical value,” added Eric Fain, group president at St. Jude Medical.

A System Supported by Clinical Research

The benefit of FFR has been supported by a number of clinical trials, including FAME and FAME 2, which demonstrated that St. Jude Medical PressureWireTM measurement technology can improve patient outcomes and reduce costs of care in patients with stable coronary artery disease. Primary outcome two-year data from the FAME 2 trial showed that in patients with at least one significant coronary blockage with an FFR value of at least .80, FFR-guided PCI plus medical therapy reduced urgent revascularization by 77 percent compared to medical therapy alone.

Two clinical trials – ILUMIEN I and OPTIMIZE PCI – are currently underway to further develop the body of clinical evidence supporting OCT technology.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit or follow us on Twitter @SJM_Media.

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 December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2014. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

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