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Launch of Trial OCT-Guided Stent Implantation vs IVUS and Angiography-Guided PCI


Launch of Trial OCT-Guided Stent Implantation vs IVUS and Angiography-Guided PCI

Image provided courtesy of St. Jude Medical, Inc.

Building on ILUMIEN I and ILUMIEN II, ILUMIEN III will compare St. Jude Medical’s OCT imaging to intravascular ultrasound and angiography to further shape the standard of care for cardiovascular patients

ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the launch of the ILUMIEN III clinical trial, a prospective, international, randomized trial evaluating the clinical benefits of the company’s optical coherence tomography (OCT) guidance during stent implantation. The ILUMIEN III study will compare OCT-guided stent implantation to implantation guided by intravascular ultrasound (IVUS) or angiography alone, diagnostic tools that offer less resolution than OCT during intravascular assessments and percutaneous coronary intervention (PCI).

The ILUMIEN III study is the largest multicenter randomized study to date to compare PCI outcomes associated with all three imaging tools. By assessing each diagnostic system head-to-head, the study should offer clear insight into OCT’s ability to influence clinical outcomes.

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The first patient enrolled within the ILUMIEN III trial was randomized at Columbia University Medical Center and underwent PCI guided by the St. Jude Medical Optis™ Integrated PCI optimization system.

We are excited about ILUMIEN III because this is the first randomized study of its kind to directly compare patient outcomes associated with guidance by OCT, IVUS or angiography during PCI,

said Dr. Ziad A. Ali, associate director of translational medicine at the Columbia University Medical Center’s Center for Interventional Vascular Therapy and principal investigator of the ILUMIEN III study.

ILUMIEN III is unique because we will be specifically assessing the utility of OCT in imaging guided PCI and gaining valuable insight into how OCT imaging can help shape patient care.

During PCI procedures, physicians use diagnostic imaging to make decisions related to stent sizing and to assess how to best keep the artery expanded to restore blood flow to the heart. One key factor in reducing stent failure is increasing the minimal stent area (MSA) and securing appropriate stent expansion during PCI to restore blood flow, a process commonly known as revascularization.

Previous research, including findings from the ILUMIEN I and ILUMIEN II studies, has shown that with superior resolution over IVUS and angiography, St. Jude Medical’s OCT imaging technology can influence pre- and post-PCI decision making, stent sizing and deployment. The ILUMIEN III study is the next step in assessing the benefits of OCT guidance in relation to first generation imaging tools.

The ILUMIEN III trial aims to enroll up to 420 patients at up to 35 sites across Europe, the U.S. and Japan. All patients will undergo PCI for stable or unstable angina (chest pain caused by insufficient blood flow to the heart), silent ischemia (restricted blood flow to the heart that causes no chest pain), or patients who’ve suffered NSTEMI or STEMI heart attacks due to arterial blockages. Patients will be randomized to undergo PCI with either OCT, angiography or IVUS and the primary endpoint will be the degree of minimum stent area achieved.

Physicians assessing patients in the ILUMIEN III study will employ the St. Jude Medical Optis Integrated and ILUMIEN™ Optis™ PCI optimization systems to assess patients randomized to OCT-guided stent implantation.

The launch of ILUMIEN III is an important step in assessing St. Jude Medical’s OCT technology and its ability to improve stent implantation over first generation diagnostic tools,

said Dr. Mark Carlson, chief medical officer at St. Jude Medical.

The study builds on important research showing the benefits of OCT imaging in supporting clinical decision making, and we’re excited to have this important trial underway.

About Optical Coherence Tomography Imaging
St. Jude Medical’s OCT technology is an intravascular imaging tool that uses light to provide anatomical images of disease morphology and automated measurements. With OCT technology, physicians can visualize and measure important vessel characteristics that are otherwise not visible or difficult to assess with the older imaging technology. As a result, OCT can provide automated, highly accurate measurements that can help guide stent selection and deployment and assess stent placement to help ensure successful procedures. This can potentially minimize the need for repeat revascularization.

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 January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2015. 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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