St. Jude Medical (NYSE:STJ) today announced CE Mark approval of its Ilumien Optis PCI optimization system, designed to help physicians assess and treat patients with coronary artery disease.
Ilumien Optis will launch in Europe next week during EuroPCR, the St. Paul, Minn., headquartered company said in a press release.
"This next-generation system delivers critical information to physicians about the location and severity of disease within the coronary arteries, potentially resulting in better medical decision-making and overall cost-effective treatment," Frank Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division, said in a press statement.
Ilumien Optis launched in Japan in March. An earlier version, Ilumien, got the marketing go-ahead in 2011 in the U.S. and in Europe.
Ilumien Optis provides enhancements to the Ilumien system, including first-in-kind stent planning software tools to aid in the treatment of coronary artery disease. This new version of St. Jude’s Ilumien platform combines the company’s PressureWire Aeris wireless fractional flow reserve technology with its Dragonfly JP imaging catheter.
The FFR tech measures the flow of blood across lesions in the arteries that feed the heart muscle, so that cardiologists can determine whether a stent is needed. The OCT tech uses near-infrared light to provide images of the lesions to measure pressure inside the coronary arteries, St. Jude said.
Featuring a faster, high-powered laser, Ilumien Optis offers twice the resolution for microscopic examination of disease inside the artery to assist with stent placement, according to the company. And, 3D vessel reconstruction offers a 360-degree panoramic view of the vessel, making it easier for physicians to visualize the area they are treating. St. Jude is the only company to provide these tools together in an integrated platform, the company notes.
"OCT technology has become increasingly important to help diagnose and treat patients with coronary artery disease," Dr. Giulio Guagliumi, Cardiovascular Department of Ospedale Papa Giovanni XXIII, Bergamo, Italy, said in a press statement.
"The Ilumien Optis system is a significant advancement in intravascular imaging technology allowing physicians to comprehensively assess more vessel in less time and more easily plan their PCI procedure," he continued. "The three-dimensional format of the ILUMIEN OPTIS system provides a more true-to-life perspective of the arteries, which allows for individual decision making and precise guidance of stent placement to optimize coronary interventions."
According to the European Heart Network, the financial burden for EU health care systems related to cardiovascular diseases was estimated at just under €110 billion in 2006, which represents around 10% of the total health care expenditure in the EU, St. Jude pointed out. About one-fifth of that health care expenditure is due to coronary artery disease, the company said.
St. Jude in December enrolled the 1st of 500 patients in the Ilumien I clinical trial of its PressureWire Aeris fractional flow reserve device. The study aims to show the best way to use optical coherence tomography during coronary angiography procedures using the PressureWire Aeris.
