St. Jude Medical’s Ilumien Optis 3-D PCI Optimization System Approved in Europe
May 16, 2013—St. Jude Medical, Inc. (St. Paul, MN) announced CE Mark approval of the Ilumien Optis percutaneous coronary intervention (PCI) optimization system, a comprehensive disease assessment tool for treating patients with coronary artery disease (CAD). The company announced in March that the Ilumien Optis system was approved in Japan.
According to St. Jude Medical’s press release, the Ilumien Optis system provides enhancements to St. Jude Medical’s Ilumien system, including newly developed stent planning software tools to aid in the treatment of CAD. The Ilumien platform integrates fractional flow reserve (FFR) technology, which measures pressure inside the coronary arteries, and intravascular optical coherence tomography (OCT) imaging technology.
St. Jude Medical stated that the new Ilumien Optis system features a faster, high-powered laser. To assist with stent placement, the system provides twice the resolution for microscopic examination of disease inside the artery. The real-time, three-dimensional reconstruction offers a 360° panoramic view of the vessel. The OCT technology uses the Dragonfly duo-imaging catheter to capture near-infrared light imaging and measure important vessel characteristics that may be otherwise invisible or difficult to assess with older imaging technology.
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. The benefits of St. Jude Medical’s PressureWire for FFR have been supported in a number of clinical trials, including FAME and FAME 2, the company noted.
Giulio Guagliumi, MD, of the cardiovascular department of Ospedale Papa Giovanni XXIII, Bergamo, Italy, commented on the St. Jude system in the company’s announcement. Dr. Guagliumi stated, “OCT technology has become increasingly important to help diagnose and treat patients with coronary artery disease. The Ilumien Optis system is a significant advancement in intravascular imaging technology, allowing physicians to comprehensively assess more vessel in less time and more easily plan their PCI procedure. The three-dimensional format of the Ilumien Optis system provides a more true-to-life perspective of the arteries, which allows for individual decision making and precise guidance of stent placement to optimize coronary interventions.”