St. Jude Medical’s diagnostic technology receives CE mark


St. Jude Medical announced it has received European CE mark approval for its Ilumien system, the first integrated diagnostic technology that combines optical coherence tomography and fractional flow reserve technologies on one platform. The combined system offers physicians advanced physiological and anatomical insight to improve the diagnosis and treatment of coronary artery disease.

This novel diagnostic system features the PressureWire Aeris (St. Jude Medical), a wireless interventional tool that measures fractional flow reserve to evaluate the severity of blood flow blockages in the coronary arteries, and the C7-XR (St. Jude Medical) optical coherence tomography diagnostic imaging technology with Extreme Resolution, a first-to-market intravascular imaging technology that allows physicians to visualise and measure important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies.


Combined, the two technologies enable the optimisation of percutaneous coronary intervention by assisting physicians in identifying culprit lesions responsible for ischaemia and by providing physicians with precise measurements of lesion dimensions and vessel size and structure.


“The Ilumien system provides me and my colleagues with an easy-to-use, flexible solution that combines optical coherence tomography and fractional flow reserve technology on one system,” said Evelyn Regar, associate professor, Department of Interventional Cardiology Thoraxcenter in Rotterdam, The Netherlands. “Having these two cutting edge technologies together is a welcome advancement for therapy guidance, allowing me to choose the right tools for each patient situation.”


Additionally, Ilumien features the Wi-Box, a wireless device that enables the system to receive aortic pressure readings from the catheterisation lab wirelessly. The Wi-Box allows physicians and staff a completely cable-free fractional flow reserve solution, combining the ease of use of a built-in system with the cost efficiency of a mobile platform.


The C7-XR system with the C7 Dragonfly imaging catheter and the PressureWire Aeris were launched in Europe in 2009.


About fractional flow reserve (FFR)

Fractional flow reserve (FFR) is an index determining the functional severity of narrowings in the coronary arteries as measured by PressureWire Certus and PressureWire Aeris. FFR specifically identifies which coronary narrowings are responsible for producing ischaemia, and it is used to direct coronary interventions and assess results for improved treatment outcomes.


Current data show that physiological assessment using FFR prior to placement of coronary stents helps physicians better optimise clinical outcomes by determining which specific lesion or lesions are responsible for a patient’s ischaemia. In January 2009, St. Jude Medical announced results from the landmark FAME (Fractional flow reserve vs. angiography in multivessel evaluation) study, a randomised, prospective, multicentre trial. The study enrolled 1,005 patients with multivessel coronary artery disease and compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography. The 12-month results, published on the 15 January 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiovascular events (MACE), such as death, myocardial infarction or repeat revascularisation, were reduced by 30% for patients whose treatment was guided by FFR rather than by standard angiography alone.


About optical coherence tomography (OCT)

Optical coherence tomography (OCT) is a leading imaging technology platform that aids physicians in the diagnosis and treatment of cardiovascular disease. OCT utilises near-infrared light to create images to visualise and measure important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies- such as fluoroscopy and intravascular ultrasound (IVUS). OCT can be especially important for the assessment of stent placement because the high-resolution images show precisely how the stent is holding the artery open and whether it is positioned correctly against the artery wall, optimising treatment and follow-up strategies.