St. Jude Medical announced on 11 March 2013, the launch of its Ilumien Optis system, a next-generation technology, according to the company, which is designed to help physicians make personalised stenting decisions based on each patient’s unique anatomy and disease state.
The new Ilumien Optis system is a combined fractional flow reserve and intravascular OCT imaging technology platform. Together, fractional flow reserve and OCT offer physicians a physiological and anatomical view of the coronary vessels to help diagnose and treat coronary artery disease. The Ilumien Optis system provides enhancements to the Ilumien system, including stent planning software tool.
“The Ilumien Optis system enables a higher image resolution, and thus makes it possible for us to analyse difficult anatomical structures, allowing me to focus on diagnostic and treatment strategies. 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,” says Takashi Akasaka of Wakayama Medical University, Japan.
The PressureWire Aeris Wireless Fractional Flow Reserve Measurement System is intended to collects 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 fractional flow reserve 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 new Ilumien Optis system uses the DragonflyJP Imaging Catheter to capture near-infrared light imaging and measure important vessel characteristics. New high resolution setting and real-time, three-dimensional reconstruction with the Ilumien Optis provide a 360-degree panoramic view of the vessel, which makes it easier for physicians to visualise the anatomy they are treating.
The fractional flow reserve and OCT measurements captured by the Ilumein Optis system allow physicians to more easily differentiate plaque build-up and determine if the narrowed arteries are causing ischaemia, or a restriction in blood flow, ultimately assisting in stent placement. Three-dimensional representation enables better visualisation in preparation for stenting and evaluation of the stent’s position once placed. These advanced functionalities have previously only been available off-line. Three-dimensional vessel reconstruction offers a better picture, and real-time analysis streamlines workflow, potentially helping physicians diagnose their patients more quickly, according to the company.
“We are very pleased to offer the Ilumien Optis system in Japan, which is a world leader in imaging technology utilisation,” said William Phillips, president of St Jude Medical Japan. “The new system is the latest in PCI optimisation 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 fractional flow reserve have been supported in a number of clinical trials, including FAME (Fractional flow reserve vs. angiography for multivessel evaluation) trial and FAME II (Fractional flow reserve guided percutaneous coronary intervention plus optimal medical treatment vs. optimal medical treatment) trial. The trials demonstrated the important role fractional flow reserve plays in improving patient care. Results from the original FAME trial found that instances of major adverse cardiovascular events (MACE) were reduced in patients whose treatment was guided by fractional flow reserve rather than by standard angiography alone. The FAME II study revealed the number of patients returning to the hospital for urgent care was 86% lower for patients with stable coronary artery disease whose stenting procedure was guided by fractional flow reserve than for those who received medical therapy alone.
Ilumien Optis has both English and Japanese language options.