ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the company has secured CE Mark and FDA clearance for the new OPTISTM Integrated System. The system is a departure from traditional, mobile cart-based diagnostic tools and advances percutaneous coronary intervention (PCI) optimization via direct installation into a hospital’s cardiac catheterization laboratory, fully integrating optical coherence tomography (OCT) and fractional flow reserve (FFR) into PCI workflow.
The approval of the OPTIS Integrated system marks the launch of the world’s first PCI optimization system to offer OCT and angiography co-registration, which supports procedural decisions by providing high-resolution, 3-D OCT views of coronary anatomy while mapping the exact location of physician’s current view via angiogram. The OPTIS Integrated system also integrates St. Jude Medical PressureWire™ fractional flow reserve (FFR) measurement technology to provide access to critical hemodynamic information during PCI.
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