CE mark approval for percutaneous coronary intervention optimisation system


St Jude Medical launches Ilumien Optis combining Fractional Flow Reserve and intravascular Optical Coherence Tomography

St Jude Medical has announced CE mark approval for its Ilumien Optis PCI Optimisation System.

The technology is designed to provide physicians with a comprehensive coronary artery disease assessment and is the only device that integrates both Fractional Flow Reserve (FFR) technology and intravascular Optical Coherence Tomography (OCT) imaging technology into one system.

The system provides enhancements to the original Ilumien solution, including first-of-its-kind stent planning software tools to aid in the treatment of coronary artery disease (CAD).

Featuring a faster, high-powered laser, the Ilumien Optis offers twice the resolution for microscopic examination of disease inside the artery to assist with stent placement. The real-time, three-dimensional 3D reconstruction offers a 360-degree panoramic view of the vessel, making it easier for physicians to visualise the area they are treating.

“OCT technology has become increasingly important to help diagnose and treat patients with coronary artery disease,” said Dr Giulio Guagliumi from the cardiovascular department at Ospedale Papa Giovanni XXIII in Bergamo, Italy.

“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 provides a more true-to-life perspective of the arteries, which allows for individual decision-making and precise guidance of stent placement to optimise coronary interventions.”

Commonly known as coronary angioplasty, percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat narrowed coronary arteries of the heart found in patients with CAD.

The OCT technology in the new system uses the Dragonfly Duo Imaging Catheter to capture near-infrared light imaging and measure important vessel characteristics otherwise invisible or difficult to assess with older imaging technology. When used with the Ilumien Optis system, the Dragonfly Duo catheter offers faster, longer pull-backs, which allow the physician to assess more of the patient’s artery in less time.

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. Knowing which specific blockages are causing the patient’s blood flow to be ineffective helps guide the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced healthcare costs.

The FFR and OCT measurements captured by the system allow physicians to more easily differentiate plaque build-up and determine if the narrowed arteries are causing a restriction in blood flow, ultimately assisting in stent placement. The automated stent planning tools provide immediate information for assessment and real-time analysis, which is intended to streamline workflow, potentially helping physicians diagnose their patients more quickly.

You may also like