St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first patient enrollment in its ILUMIEN I clinical study. This observational study is designed to show the optimal way Optical Coherence Tomography (OCT), an intravascular imaging technology, combined with the St. Jude Medical PressureWire™ Aeris, a wireless interventional tool that measures Fractional Flow Reserve (FFR), can guide stent implantation in patients with coronary artery disease. The study will observe and record how physicians treat patients while undergoing Percutaneous Coronary Intervention (PCI), and will also measure outcomes according to various procedural parameters. Commonly known as coronary angioplasty, PCI is a non-surgical procedure used to treat narrowed coronary arteries of the heart found in coronary artery disease. Gathering this information will assist in establishing guidance parameters for optimal stenting, which may result in improved clinical outcomes for patients undergoing PCI.
“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,” said Dr. David Holmes, ILUMIEN I Global Steering Committee Member and U.S. Coordinating Investigator from Mayo Clinic in Rochester, Minn. “The ILUMIEN I study is an important step towards guiding physician decisions during PCI, ultimately leading to better clinical outcomes.”
OCT images allow physicians to visualize and measure important vessel characteristics for stent planning. Following stent placement, the high-resolution images offered by OCT show precisely how the stent is holding the artery open and whether it is positioned correctly against the artery wall, informing treatment and follow-up strategies. When combined with the PressureWire Aeris to measure FFR, the use of OCT potentially minimizes the need for urgent hospital visits, repeat revascularizations or other complications.
"OCT offers a remarkably clear image from inside the coronary vessel, which is something we haven't been able to see previously," said Prof. William Wijns, ILUMIEN I Global Steering Committee Member and International Coordinating Investigator from the Cardiovascular Center, Aalst, Belgium. "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."
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