“Conducting rigorous clinical science is how we advance patient care, and, like the seminal FAME study that was carried out over 10 years ago, I believe DEFINE GPS has the potential to change the current standard of care in PCI,” said Principal Investigator, Dr. Allen Jeremias, at St Francis Hospital in Roslyn, New York State. “PCI has made a major positive impact on many coronary artery disease patients’ lives, but when we look back at all the major, high-quality stent trials over the past 20 years we see that around 20-30% of patients continue to have recurring chest pain at one year after receiving treatment. With DEFINE GPS we will be able to definitively determine if a physiology-based PCI approach results in superior patient outcomes compared to standard angioplasty.”

PCI is an image-guided, minimally-invasive treatment to open a coronary artery blockage (stenosis) that is causing a reduced blood flow (ischemia) to heart tissue. Under the current standard of care, clinicians navigate a balloon catheter and coronary stent to the treatment area using interventional X-ray guidance (a coronary angiogram). In the DEFINE GPS study, an iFR pullback measurement, which uses pressure wires to map the physiological profile of disease distribution along the length of the affected vessel, will be overlaid on the angiogram to provide more precise information on where to treat within the vessel. The study will also use iFR to measure if the treatment succeeds in restoring sufficient blood flow to prevent ischemia or if further treatment is warranted.

“iFR continues to be adopted in clinical practice, with mounting evidence that this innovative technology contributes to improved outcomes, reduced costs [2, 3, 4] and enhanced patient experiences,” said Chris Landon, Senior Vice President and General Manager Image Guided Therapy Devices at Philips. “This major study will provide a definitive answer to the question of whether a functional guidance strategy throughout the procedure demonstrates superior outcomes and reduces costs. The study has the potential to drive a significant improvement in clinical practice, and it’s a prime example of Philips’ commitment to providing a strong evidence base for the benefits of its healthcare innovations.”

Philips Image Guided Co-Registration System – SyncVision – is part of the company’s unique portfolio of systems, smart devices, software and services available on its Image Guided Therapy System – Azurion. In addition to advanced imaging systems, the portfolio includes coronary imaging catheters, coronary atherectomy and coronary crossing devices, specialty balloons, flow wires, and pressure wires such as Philips’ new OmniWire – a unique solid-core pressure wire that enhances the ability to maneuver the wire in the patient’s circulatory system.

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