Patients using Royal Philips’s (NYSE:PHG) Stellarex drug-coated balloon maintained blood flow through the treated segment of diseased arteries at three years in a pair of clinical trials.
Stellarex is designed to restore and maintain blood flow in the superficial femoral artery and peripheral arteries. It’s coated using the company’s EnduraCoat technology to elute the drug paclitaxel. Spectranetics won FDA pre-market approval for the device in 2017, before being acquired by Royal Philips later that year.
Three-year results from the Illumenate pivotal trial showed that 64.2% of patients treated with Stellarex were able to maintain blood flow through the treated segment of the diseased artery, compared to only 51% of people treated with an uncoated balloon. The randomized trial included patients with the highest rates of comorbidities like diabetes and renal insufficiency; 43.9% had severely calcified lesions, Philips said.
A second Illumenate European randomized clinical trial showed that, at 36 months, 67.5% of Stellarex-treated patients maintained blood flow, compared to 59.9% in the uncoated balloon group.
“The three-year data of the Illumenate pivotal trial and the Illumenate EU RCT add to the robust and consistent multi-year data of the Stellarex program,” Dr. Jay Mathews, who presented the data, said in a press release. “The demonstrated durability of Stellarex in the complex patient pool of the Illumenate pivotal trial, which are patients that are at high risk for restenosis, a recurring blockage, is unique in the industry. Moreover, we continue to see no significant difference in mortality rates between patients treated with Stellarex and those treated with uncoated balloons, which confirms our confidence in the safety profile of Stellarex.”
Both studies showed no significant difference in mortality compared to uncoated balloon treatment. The Stellarex arm had a mortality rate of 10.1% in the Illumenate pivotal, compared to 11% for patients treated with an uncoated balloon. The European study’s mortality rate was 9.4% for Stellarex patients, compared with 8.5% for uncoated balloon patients.
“We are committed to providing clinically proven image-guided therapy solutions that enhance the procedure and positively impact patient outcomes,” added image-guided therapy chief business leader Bert van Meurs. “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.”