St. Jude Medical has received CE Mark approval for its Ilumien Optis Percutaneous Coronary Intervention (PCI) Optimization System.
PCI, also known as coronary angioplasty, is a non-surgical procedure designed to provide disease assessment tool for treating narrowed coronary arteries of the heart in patients with CAD.
The Ilumien platform incorporates both Fractional Flow Reserve (FFR) technology and intravascular Optical Coherence Tomography (OCT) imaging technology in a single system.
Featuring high-powered laser, the Ilumien Optis system also provides the resolution for microscopic examination of disease inside the artery twice to assist with stent placement.
The real-time, three-dimensional (3-D) reconstruction is claimed to offer a 3600 panoramic view of the vessel.
Ospedale Papa Giovanni XXIII Cardiovascular Department Giulio Guagliumi said the 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," Guagliumi added.
The OCT technology in the Ilumien Optis system uses the Dragonfly Duo Imaging Catheter to capture near-infrared light imaging and measure important vessel characteristics.
The FFR pressure guidewire is directed along the vessel, taking measurements as the guidewire is pulled back through the artery.
The FFR and OCT measurements enable to differentiate plaque build-up and to determine if the narrowed arteries are causing ischemia, ultimately assisting in stent placement that provides information for assessment and real-time analysis.
St. Jude Medical Cardiovascular and Ablation Technologies Division president Frank Callaghan said, "This next-generation system delivers critical information to physicians about the location and severity of disease within the coronary arteries, potentially resulting in better medical decision-making and overall cost-effective treatment."
Image: 3-D image of a stent inside a coronary artery taken using the Ilumien Optis. Photo: Courtesy of St. Jude Medical.