Next-Generation ILUMIEN OPTIS System From St. Jude Medical Provides Real-Time 360˚ Panoramic View of the Arteries
ST. PAUL, Minn. — Oct. 22, 2013 — St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) approval and launch 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 the U.S. during the 2013 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
The ILUMIEN platform works by integrating both fractional flow reserve (FFR) technology and intravascular optical coherence tomography (OCT) imaging technology. There are currently more than 1,200 published articles with clinical evidence supporting St. Jude Medical’s FFR and OCT technologies.
The ILUMIEN OPTIS system is the next generation of the ILUMIEN System and has several first-of-its kind enhancements, including automated measurements and stent planning software tools. The OCT imaging technology provides a real-time, three-dimensional (3-D) reconstruction of the patient’s vessel, making it easier for physicians to visualize the area they are treating. The new system offers twice the resolution of the earlier generation, which allows for better microscopic examination of disease inside the artery to assist with stent placement.
“The ILUMIEN OPTIS is an advancement that offers an eye-opening perspective of the coronary arteries, providing me with a more complete understanding about the extent of the patient’s disease,” said Dr. Matthew J. Price, Director of the Cardiac Catheterization Laboratory at Scripps Green Hospital/Scripps Clinic in La Jolla, California. “The high-definition, three-dimensional format and the new stent placement tools allow me to create a treatment plan tailored for each patient’s unique vasculature – and to confirm that I get the best possible stent result. That makes my life easier and helps the patient, too.”
The OCT technology in the new ILUMIEN OPTIS system uses the Dragonfly Duo Imaging Catheter to capture near-infrared light images and measures important vessel characteristics otherwise invisible or difficult to assess with older imaging technology. The catheter offers faster, longer pull-backs, which allows 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 benefits of St. Jude Medical’s PressureWire FFR Measurement technology have been supported in a number of clinical trials, including the landmark FAME and FAME 2 studies. Results from the original FAME trial found that instances of major adverse cardiovascular events (MACE) were significantly reduced in patients whose treatment was guided by the company’s PressureWire rather than by angiography alone. The FAME 2 study revealed that stenting guided by the St. Jude Medical PressureWire to address significant blood flow blockages along with medical treatment is better than medical treatment alone. Specifically, instances of hospital re-admission because of an urgent revascularization were reduced by 86 percent when the PressureWire was used. These results add to the growing body of evidence demonstrating improved patient outcomes and cost-savings with PressureWire-guided stenting.
Attendees can visit St. Jude Medical at booth 617 at TCT during exhibition hours on Oct. 29, 30 and 31. TCT is the annual scientific symposium of the Cardiovascular Research Foundation.
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