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St. Jude receives CE mark and FDA approvals for new OPTIS Integrated System

Medical device manufacturer St. Jude Medical has received CE mark and FDA approvals for its new OPTIS Integrated System.

The system will be used to advance non-surgical procedure, percutaneous coronary intervention (PCI), which has been developed to eliminate coronary blood flow blockages and restore blood flow to the heart.

OPTIS offers high-resolution and 3-D OCT views of coronary anatomy while mapping the exact location of physician’s current view through angiogram, said the company.

In addition, the system incorporates PressureWire fractional flow reserve (FFR) measurement technology, which allows in accessing critical hemodynamic information during PCI.

Italy Ospedale Papa Giovanni XXIII interventional cardiologist Giulio Guagliumi said: "PCI as a procedure has been around for decades, but only recently has the procedure been optimized by new diagnostic tools that can improve clinical outcomes."

St. Jude Medical group president Eric Fain said: "We developed the OPTIS Integrated system in response to physicians who wanted a more integrated system that combined angiography, the current standard of care for intravascular imaging, with diagnostic technology that adds clinical value."

The company will showcase the system at the Transcatheter Cardiovascular Therapeutics (TCT) 2014, in Washington, DC.