St. Jude Medical Announces European Approval of 3-D Vessel Reconstruction Technology to Aid Physicians in Stent Placement

St. Jude Medical, Inc. STJ, a global medical device company, today announced CE Mark approval of its ILUMIEN^™ OPTIS^™ PCI Optimization System^™, a new technology designed to provide physicians with a comprehensive disease assessment tool for treating patients with coronary artery disease (CAD). The system will be on display for the first time in Europe during EuroPCR. The ILUMIEN OPTIS system provides enhancements to the ILUMIEN^™ system, including first-of-its-kind stent planning software tools to aid in the treatment of CAD. The ILUMIEN platform integrates both Fractional Flow Reserve (FFR) technology to measure pressure inside the coronary arteries and intravascular Optical Coherence Tomography (OCT) imaging technology, in one system. Featuring a faster, high-powered laser, the ILUMIEN OPTIS system offers twice the resolution for microscopic examination of disease inside the artery to assist with stent placement. The real-time, three-dimensional (3-D) reconstruction offers a 360-degree panoramic view of the vessel, making it easier for physicians to visualize the area they are treating. St. Jude Medical is the only company to provide these tools together in an integrated platform. Commonly known as coronary angioplasty, Percutaneous Coronary Intervention (PCI) is a non-surgical procedure used to treat narrowed coronary arteries of the heart found in patients with CAD. The OCT technology in the new ILUMIEN OPTIS system uses the Dragonfly^™ Duo Imaging Catheter to capture near-infrared light imaging and measure important vessel characteristics otherwise invisible or difficult to assess with older imaging technology. When used with the ILUMIEN OPTIS system, the Dragonfly Duo catheter offers faster, longer pull-backs, which allow the physician to assess more of the patient's artery in less time. The wireless PressureWire^™ Aeris^™ technology that is integrated into the platform measures pressure differences in blood flow within the coronary arteries leading to the heart, and determines the severity of any narrowings or blockages. The FFR pressure guidewire is directed along the vessel, taking measurements as the guidewire is pulled back through the artery. Knowing which specific blockages are causing the patient's blood flow to be ineffective helps guide the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced health care costs. The FFR and OCT measurements captured by the ILUMIEN OPTIS system allow physicians to more easily differentiate plaque build-up and determine if the narrowed arteries are causing ischemia (a restriction in blood flow), ultimately assisting in stent placement. The automated stent planning tools provide immediate information for assessment and real-time analysis, which is intended to streamline workflow, potentially helping physicians diagnose their patients more quickly.