St. Jude Medical (Minneapolis, MN) has launched its OPTIS Mobile System, which couples optical coherence tomography (OCT) and angiography co-registration with fractional flow reserve (FFR) technology for hospitals with multiple catheterization labs, in Europe and Japan.
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Driven by a global increase in vascular disease and enabled by advances in technology, the catheterization lab allows physicians to use minimally invasive percutaneous coronary intervention (PCI) procedures that give patients an alternative to open heart surgery with the goal to improve patient outcomes, shorten hospital stays, and reduce hospital costs. The OPTIS System offers physicians an efficient way to optimize PCI procedures for the treatment of vascular disease by combining diagnostic tools designed to improve patient outcomes into one portable device.
Employing a combination of technology previously available only in the company's OPTIS Integrated System, the OPTIS Mobile System serves to help physicians make improved stenting decisions based on high-resolution, 3D OCT views of coronary anatomy while simultaneously mapping their exact location via angiogram. The system also integrates the company's PressureWire FFR measurement technology for detailed coronary hemodynamic (circulatory) information during PCI. Clinical data has shown that the physiological measurements provided by the FFR technology can improve outcomes and reduce healthcare costs over traditional diagnostic imaging tools.
Sometimes referred to as coronary angioplasty, PCI is a catheter-based procedure designed to open coronary blockages or plaque buildup and restore blood flow to the heart. Traditionally, physicians have relied on either angiography or intravascular ultrasound to guide PCI procedures. The company's ILUMIEN System first combined OCT and FFR technology to enable a more detailed, physiological, and anatomical analysis of blood flow blockages inside the coronary vessels.
The ILUMIEN I and ILUMIEN II studies have shown that the company's OCT imaging technology can influence pre- and post-PCI decision-making, stent sizing, and deployment. The company-sponsored FAME body of evidence demonstrated that PressureWire FFR measurement technology can improve patient outcomes and reduce costs in patients with stable coronary artery disease.
A multicenter ILUMIEN III: OPTIMIZE PCI clinical trial is currently underway to further develop the body of clinical evidence supporting OCT technology in relation to first generation imaging tools.
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