St. Jude Medical Announces FDA Approval and Launch of Ilumien Optis System

October 22, 2013—St. Jude Medical, Inc. (St. Paul, MN) announced the US Food and Drug Administration (FDA) approval and market launch of its next-generation comprehensive disease assessment tool for percutaneous coronary intervention in patients with coronary artery disease. The Ilumien Optis PCI Optimization system will be introduced during the 2013 Transcatheter Cardiovascular Therapeutics scientific symposium, which is being held on October 27 to November 1, in San Francisco, California.

According to St. Jude Medical, the Ilumien platform helps physicians better understand which arteries should be treated and how best to treat them. It works by integrating both fractional flow reserve technology to measure blood flow blockage inside the coronary arteries and intravascular optical coherence tomographic (OCT) imaging technology.

The company noted that the Ilumien Optis system is the next generation of the St. Jude Ilumien system. The Ilumien Optis 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 reconstruction of the patient's vessel. 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 OCT technology in the 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 pullbacks, which allows the physician to assess more of the patient's artery in less time.

The platform's wireless PressureWire Aeris technology measures pressure differences in blood flow within the coronary arteries and determines the severity of any narrowings or blockages, which aids the interventional cardiologist in determining the vessels that require stenting.

The fractional flow reserve and OCT measurements captured by the Ilumien Optis system allow physicians to more easily differentiate types of plaque buildup and determine if the narrowed arteries are causing ischemia, ultimately assisting in stent placement. The automated stent planning tools provide immediate information for assessment and real-time analysis, which may streamline workflow and help physicians diagnose their patients more quickly.

“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,” commented Matthew J. Price, MD, in the company's press release. Dr. Price is Director of the Cardiac Catheterization Laboratory at Scripps Green Hospital/Scripps Clinic in La Jolla, California. He continued, “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.”