St. Jude Releases Optis Integrated System

St. Paul, Minn.-based St. Jude Medical Inc. has released the Optis Integrated system, which combines OCT (optical coherence tomography) imaging with angiography, following CE mark approval and 510(k) clearance from the U.S. Food and Drug Administration. 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 OCT and fractional flow reserve (FFR) into PCI workflow.

The approval of the Optis Integrated system is aimed at supporting 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. It also integrates St. Jude’s Pressurewire FFR measurement technology to provide access to critical hemodynamic information during PCI.

“As the interventional cardiology landscape has shifted to the treatment of more complex patients, intravascular imaging and fractional flow reserve have emerged as critical tools for enabling physicians to make more informed treatment decisions during PCI,” said Gregg Stone, M.D., interventional cardiologist and director of cardiovascular research and education at Columbia Presbyterian Medical Center and the Cardiovascular Research Foundation. “By integrating these tools directly into cath lab infrastructure, we can enhance access to technology and have them readily available during PCI procedures.”

Percutaneous coronary intervention, or coronary angioplasty, is a non-surgical 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 advances PCI optimization technology further by offering 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.

“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,” Giulio Guagliumi, M.D., an interventional cardiologist with Ospedale Papa Giovanni XXIII in Bergamo, Italy. “On demand FFR and OCT can support clinical decision making by providing highly-detailed intracoronary arterial views, which improves PCI, especially in complex cases. Furthermore, the resolution of OCT over intravascular ultrasound can be imperative in reducing challenges such as stent fracture and edge dissection.”

“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,” added Eric Fain, group president at St. Jude Medical.