St. Jude Medical Launches Optis Integrated System

September 15, 2014—St. Jude Medical, Inc. announced that the company has secured European CE Mark approval and United States Food and Drug Administration clearance for the Optis integrated system. The system was introduced at the Transcatheter Cardiovascular Therapeutics 2014 scientific symposium in Washington, DC.

According to the company, the system departs 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 the PCI workflow.

Optis is a PCI optimization system that offers OCT and angiography coregistration, which supports procedural decisions by providing high-resolution, three-dimensional OCT views of coronary anatomy while mapping the exact location of the physician’s current view via angiogram. The Optis system also includes St. Jude Medical’s PressureWire FFR measurement technology to provide access to critical hemodynamic information during PCI.

In the company’s press release, Gregg Stone, MD, commented, “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. By integrating these tools directly into cath lab infrastructure, we can enhance access to technology and have them readily available during PCI procedures.” Dr. Stone is an interventional cardiologist and Director of Cardiovascular Research and Education at Columbia Presbyterian Medical Center and the Cardiovascular Research Foundation in New York, New York.

St. Jude Medical noted that the company originally combined OCT and FFR technology in the Ilumien Optis and Optis integrated systems to enable a more detailed physiologic and anatomic analysis of blood flow blockages inside the coronary arteries.

The Optis integrated system offers a side-by-side view of OCT and angiography via a coregistration 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.

In the company’s press release, Giulio Guagliumi, MD, commented, “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. 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.” Dr. Guagliumi is an interventional cardiologist with Ospedale Papa Giovanni XXIII in Bergamo, Italy.