Following European approval back in May, St. Jude Medical‘s ILUMIEN OPTIS PCI Optimization System is now cleared by the FDA for artery analysis in preparation for stent placement or other therapeutic procedures. The system uses fractional flow reserve (FFR) technology to measure the intra-arterial pressure as well as optical coherence tomography (OCT) to have a visual look at the state of the arterial lumen.
The company’s PressureWire guidewire is used for FFR measurement and the Dragonfly Duo catheter scans the vessel walls with a near-infrared laser to create a 3D image that can be viewed in a variety of ways.
From St. Jude:
The FFR and OCT measurements captured by the ILUMIEN OPTIS system allow physicians to more easily differentiate different types of plaque build-up and determine if the narrowed arteries are causing a restriction in blood flow (ischemia), ultimately assisting in stent placement. The automated stent planning tools provide immediate information for assessment and real-time analysis, which may streamline workflow and help physicians diagnose their patients more quickly.
The benefits of St. Jude Medical’s PressureWire FFR Measurement technology have been supported in a number of clinical trials, including the landmark FAME and FAME 2 studies. Results from the original FAME trial found that instances of major adverse cardiovascular events (MACE) were significantly reduced in patients whose treatment was guided by the company’s PressureWire rather than by angiography alone. The FAME 2 study revealed that stenting guided by the St. Jude Medical PressureWire to address significant blood flow blockages along with medical treatment is better than medical treatment alone. Specifically, instances of hospital re-admission because of an urgent revascularization were reduced by 86 percent when the PressureWire was used. These results add to the growing body of evidence demonstrating improved patient outcomes and cost-savings with PressureWire-guided stenting.
Flashbacks: St. Jude’s ILUMIEN OPTIS PCI Optimization System with FFR, OCT Cleared in EU; St. Jude’s ILUMIEN OPTIS Combination FFR/OCT System for Stent Placement Unveiled in Japan
Press release: New 3-D Vessel Reconstruction Technology to Aid Physicians in Stent Placement Launches in the US