Philips (NYSE:PHG) said yesterday that it enrolled the first patient in a U.S. investigational device exemption trial for its Stellarex drug-coated balloon.
The 354-patient Illumenate Below-the-Knee study is designed to assess the device’s safety and effectiveness compared to percutaneous transluminal angioplasty in people with critical limb ischemia.
“Several studies have shown the safety and durability benefits of the Stellarex balloon,” principal investigator Dr. Mahmood Razavi said in prepared remarks. “This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 drug-coated balloon for BTK peripheral artery disease and its safety and durability for patients. Given the challenging chronic nature of BTK PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation.”
“Peripheral artery disease below the knee is challenging and Philips is committed to providing proven clinical solutions that positively impact patient outcomes,” Christopher Barys, business leader for Philips’ image guided therapy devices unit, added. “With Stellarex BTK, we have the potential to improve patient outcomes and decrease re-admission costs for those suffering from this complex disease state, while providing clinicians with the necessary tools to confirm the right therapies for their patients.”
