Ames Gross and Catherine Matacic05.01.13
St. Jude Medical Inc. has rolled out its latest product offering in Japan. The St. Paul, Minn.-based device firm introduced the Ilumien Optis system, which the company bills as a next-generation technology designed to help physicians make personalized stenting decisions based on patients’ unique anatomy and disease state. The system combines fractional flow reserve (FFR, an index determining the functional severity of narrowing in the coronary arteries) and intravascular optical coherence tomography (OCT, an optical signal acquisition and processing method that captures micrometer-resolution, 3-D images from within biological tissue) imaging technology. Together, the capabilities allow physicians a physiological and anatomical view of the coronary vessels to help diagnose and treat coronary artery disease, according to the company. The new system adds several upgrades to the original Ilumien system, including stent planning software tool. “The Ilumien Optis system enables a higher image resolution, and thus makes it possible for us to analyze difficult anatomical structures, allowing me to focus on diagnostic and treatment strategies,” said Takashi Akasaka, M.D., of Wakayama Medical University in Wakayama, Japan. “Also, this new analytical tool will be helpful for sizing and placing the stent. This technology has become increasingly important to help efficiently diagnose and treat patients.” The PressureWire Aeris wireless FFR measurement system in the Ilumien Optis reportedly works by collecting detailed analyses of blood flow blockages in the coronary vessels to help determine which specific blockages are causing the patient’s blood flow to be ineffective. The FFR pressure guidewire is directed through the coronary arteries and across the narrowed vessel, taking measurements as the guidewire is pulled back through the narrowed part of the artery. The OCT technology in the system uses the Dragonfly JP imaging catheter to capture near-infrared light imaging and measure important vessel characteristics otherwise invisible or difficult to assess with older intracoronary imaging tools. A new high-resolution setting and real-time, 3-D reconstruction with the Ilumien Optis provide a 360-degree panoramic view of the vessel, the company claims, which makes it easier for physicians to visualize the anatomy they are treating. The FFR and OCT measurements captured by the Ilumien Optis system are intended to 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. 3-D representation enables better visualization in preparation for stenting and evaluation of the stent’s position once placed. “We are very pleased to offer the Ilumien Optis system in Japan, which is a world leader in imaging technology utilization,” said William Phillips, president of St. Jude Medical Japan. “The new system is the latest in PCI [percutaneous coronary intervention] optimization technology, and helps physicians understand the needs of each patient, ultimately resulting in better medical decision making and overall cost-effective treatment.” The benefits of FFR have been supported in a number of clinical trials, including Fame and Fame 2. The trials effectively demonstrate the important role FFR plays in improving patient care. Results from the original Fame trial found that instances of major adverse cardiovascular events were reduced in patients whose treatment was guided by FFR rather than by standard angiography alone. The Fame 2 study revealed the number of patients returning to the hospital for urgent care was 86 percent lower for patients with stable coronary artery disease whose stenting procedure was guided by FFR than for those who received medical therapy alone. Each year in Japan about 245,000 PCI procedures are performed to treat cardiovascular disease, and of those, nearly 80 percent are estimated to use imaging technology. Ilumien Optis comes with both English and Japanese language options. For 2012, St. Jude’s net sales in Japan increased by 10 percent to $456 million. The llumien system was first granted 510(k) clearance from the U.S. Food and Drug Administration in October 2011. The Optis gained clearance January this year.— MPO Staff |