Royal Philips has announced four-year results of a patient-level meta-analysis from two randomised controlled trials (RCTs) that confirmed the safety profile of its Stellarex drug-coated balloon (DCB).
The two Stellarex RCTs, ILLUMENATE EU RCT and ILLUMENATE Pivotal RCT, were conducted on 589 patients in the US and Europe followed for up to four years with high compliance on vital status data.
Stellarex .035” DCB has Philips EnduraCoat technology, a unique coating of polyethene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it.
The technology enables effective drug transfer and residency, along with increased coating durability and negligible particulate loss.
Setting itself apart from other drug-coated balloons for treating peripheral artery disease, Stellarex DCB provides top-tier patency to treat lesions with a low drug dose.
The data showed no difference in mortality between patients treated with the Stellarex DCB and those treated with percutaneous angioplasty (PTA), the current standard of care.
A significant difference in survival among patients treated with the Stellarex DCB compared to those treated with PTA was not observed.
Furthermore, no difference in cardiovascular mortality and non-cardiovascular mortality was noted between treatment with Stellarex DCB and PTA.
Philips Image Guided Therapy Devices senior vice-president and general manager Chris Landon said: “The results of this study confirm the safety and performance of our unique Stellarex low-dose drug-coated balloon.
“We are committed to providing healthcare providers with accurate and transparent data in order to help them make an informed decision on the optimal treatment for each patient with peripheral arterial disease.”
The data supports previously presented results from the ILLUMENATE RCTs, showing low mortality rates each year with no difference in rates between the two patient groups.
Last week, Philips unveiled a non-invasive ventilator, BiPAP A40 EFL for COPD patients.