St. Jude Medical OCT imaging system receives FDA and CE Mark approvals

Sept. 15, 2014
Medical device maker St. Jude Medical has secured CE Mark and FDA clearance for the company's Optis integrated system, which pairs optical coherence tomography (OCT) and fractional flow reserve (FFR) with a percutaneous coronary intervention (PCI) workflow.

Medical device maker St. Jude Medical (St. Paul, MN) has secured CE Mark and FDA clearance for the company's Optis integrated system, which pairs optical coherence tomography (OCT) and fractional flow reserve (FFR) with a percutaneous coronary intervention (PCI) workflow. The system is a departure from traditional, mobile cart-based diagnostic tools and advances PCI optimization via direct installation into a hospital's cardiac catheterization laboratory.

Related: Totally tubular: Cardiovascular OCT goes prime time

The system's approval 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, 3D OCT views of coronary anatomy while mapping the exact location of physician's current view via angiogram. The system also integrates the company's PressureWire FFR measurement technology to provide access to critical hemodynamic information during PCI.

Percutaneous coronary intervention (PCI), or coronary angioplasty, is a nonsurgical procedure designed to eliminate coronary blood flow blockages and restore blood flow to the heart. Traditionally, physicians have relied on angiography or intravascular ultrasound to guide PCI. St. Jude Medical originally combined OCT and FFR technology in the Ilumien Optis and Optis Integrated systems to enable a more detailed, physiological, and anatomical analysis of blood flow blockages inside the coronary arteries.

OPTIS Integrated offers a side-by-side view of OCT and angiography via a co-registration to "map" culprit lesions and provide the visual data necessary to guide stent selection and deployment. In addition, FFR technology allows physicians to assess the severity of blood flow blockages. Direct tableside controls allow physicians to directly drive system operations while a new user interface prioritizes image display for increased visibility and operation. Stent planning tools enable enhanced precision in determining optimal stent sizing and placement.

The benefit of FFR has been supported by a number of clinical trials, including FAME and FAME 2, which demonstrated that PressureWire measurement technology can improve patient outcomes and reduce costs of care in patients with stable coronary artery disease. Primary outcome two-year data from the FAME 2 trial showed that in patients with at least one significant coronary blockage with an FFR value of at least .80, FFR-guided PCI plus medical therapy reduced urgent revascularization by 77 percent compared to medical therapy alone.

Two clinical trials – ILUMIEN I and OPTIMIZE PCI – are currently underway to further develop the body of clinical evidence supporting OCT technology.

The system is now on display for the first time during the Transcatheter Cardiovascular Therapeutics (TCT) 2014, currently being held until Sept. 17, 2014, in Washington, DC.


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