First Patient Enrolled in St. Jude Medical's ILUMIEN I Study

December 18, 2012—St. Jude Medical, Inc. (St. Paul, MN) announced the first patient enrollment in its ILUMIEN I clinical study. The observational ILUMIEN I study is designed to show the optimal way that optical coherence tomography (OCT) combined with the St. Jude Medical PressureWire Aeris can guide stent implantation in patients with coronary artery disease. The PressureWire Aeris is a wireless interventional tool that measures fractional flow reserve (FFR).

In addition to the PressureWire Aeris, the Ilumien percutaneous coronary intervention (PCI) optimization system features the St. Jude Medical Dragonfly intravascular imaging catheter, which allows physicians to visualize and measure important vessel characteristics that are not otherwise visible or difficult to assess with older intracoronary imaging technologies. The two technologies combine to enable the optimization of PCI procedures by assisting physicians in identifying the culprit lesions responsible for ischemia. These technologies also provide physicians with precise measurements of lesion dimensions, as well as vessel size and structure.

According to the company's press release, the ILUMIEN I study will observe and record the way physicians treat patients while undergoing PCI and will also measure outcomes according to various procedural parameters. The company stated that this information will assist in establishing guidance parameters for optimal stenting, which may result in improved clinical outcomes for patients undergoing PCI.

St. Jude Medical advised that the ILUMIEN I prospective, observational study will enroll approximately 500 patients at 40 medical centers around the world. Patients will first undergo a catheterization procedure, which will include using the PressureWire Aeris to take FFR measurements and establish the severity of blood flow restriction to determine the level of treatment needed. In arteries in which FFR has determined that treatment is needed, OCT images will then be collected to help inform stent selection and placement.

After stent placement, OCT images will be collected again to help inform the physician regarding the need for additional intervention. Data will be collected before and after stenting and throughout the 12-month follow-up period to assess the impact of coronary lesion characteristics and stent deployment on patient outcomes. All collected data will be compiled and used in determining stent guidance parameters to achieve PCI optimization in both stable and unstable coronary disease patients.

“Improving patients' quality of life is our highest priority as physicians, and if we can successfully treat our patients while streamlining workflow, the benefit is even greater,” commented David Holmes, MD, in St. Jude Medical's announcement. Dr. Holmes is an ILUMIEN I Global Steering Committee Member and United States Coordinating Investigator from the Mayo Clinic in Rochester, Minnesota. Dr. Holmes added, “The ILUMIEN I study is an important step towards guiding physician decisions during PCI, ultimately leading to better clinical outcomes.”

Prof. William Wijns, ILUMIEN I Global Steering Committee Member and International Coordinating Investigator from the Cardiovascular Center, Aalst, Belgium, also commented in the press release, “OCT offers a remarkably clear image from inside the coronary vessel, which is something we haven't been able to see previously. Using this technology, I can assess important vessel characteristics before placing the stent, confirm success after placing the stent, and identify potential problem areas to quickly understand how to best treat my patient.”