Philips, a Dutch health technology company, has announced the three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE European randomized clinical triaal (EU RCT).
Image: Philips has designed the Stellarex .035 DCB featuring the EnduraCoat Technology. Photo: Courtesy of Koninklijke Philips N.V.
Philips said that the two trials are part of a series of five trials evaluating the safety and efficacy of its Stellarex .035″ low-dose DCB to restore and maintain blood flow in the superficial femoral artery and popliteal arteries in patients with peripheral arterial disease.
The results of the studies were evaluated compared to the current standard of treatment, using uncoated balloons, and the data was presented as a late-breaking trial at the New Cardiovascular Horizons Annual Conference.
The ILLUMENATE Pivotal trial results demonstrated that at 36 months, 64.2% of the patients treated with Stellarex maintained blood flow through the treated segment of the diseased artery, compared to 51.0% of the patients treated with an uncoated balloon, demonstrating continued durability of the procedure.
The patient pool for the study was the most complex in a randomized clinical trial, which included patients with the highest rates of comorbidities, while 43.9% also had severely calcified lesions.
Results from the European clinical trial EU RCT showed that at 36 months, 67.5% of the patients treated with Stellarex maintained blood flow, compared to 59.9% of the patients treated with an uncoated balloon.
The company said that for three years, both the studies presented no significant difference in mortality compared to treatment with uncoated balloons.
In addition, the mortality rate of patients treated with Stellarex in the ILLUMENATE Pivotal trial was 10.1%, compared to the mortality rate of patients treated with an uncoated balloon of 11.0%. The EU RCT showed mortality rates of 9.4% for patients treated with Stellarex, compared to 8.5%for patients treated with an uncoated balloon.
Royal Philips image guided therapy chief business leader Bert van Meurs said: “We are committed to providing clinically proven image-guided therapy solutions that enhance the procedure and positively impact patient outcomes. Stellarex is the only low-dose drug-coated balloon with a proven treatment effect at three years compared to the existing standard-of-care in the U.S. and Europe.
“The combination with our interventional imaging systems, such as the successful Azurion platform, our recently-introduced IntraSight intravascular diagnostic application platform, and associated services, enables clinicians to decide, guide, treat and confirm the appropriate peripheral vascular treatment.”
Philips has designed the Stellarex .035 DCB featuring the EnduraCoat Technology, a unique coating consisting of polyethylene glycol as the base material to restore and maintain blood flow in diseased femoral and popliteal arteries. The device was approved by the US FDA and CE marked in Europe.