Health technology firm Royal Philips has enrolled the first US patient in the Illumenate study of Stellarex 0.014 drug-coated balloon for below-the-knee (BTK) peripheral artery disease.


Image: The Stellarex 0.014 OTW drug-coated balloon is designed to restore and maintain blood flow to arteries in patients with PAD. Photo: courtesy of Koninklijke Philips N.V.

The Stellarex Illumenate BTK investigational device exemption (IDE) study is headed by principal investigators Bill Gray and Mahmood Razavi.

Razavi said: “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 (PAD) 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.”

Philips has designed the Stellarex 0.014 OTW drug-coated balloon to restore and maintain blood flow to arteries in patients with PAD

The Stellarex 0.014 drug-coated balloon already secured CE mark approval and is marketed in the Europe.

The global, prospective, randomized and multi-center trial has been designed to evaluate safety and effectiveness of the Stellarex 0.014 drug-coated balloon against percutaneous transluminal angioplasty (PTA) in patients with critical limb ischemia (CLI).

The company will recruit 354 patients at 45 sites in US, Europe and Australia in the following 12 to 18 months.

Craig Walker recruited the first US patient at the Cardiovascular Institute of the South in Houma, Louisiana.

Philips’ image-guided therapy solutions include imaging systems, smart devices, software and service, which allows clinicians to decide, guide, treat and confirm the appropriate cardiac and peripheral vascular treatment.

Philips image guided therapy devices business leader Christopher Barys said: “Peripheral artery disease below the knee is challenging and Philips is committed to providing proven clinical solutions that positively impact patient outcomes.

“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.”

Philips provides diagnostic imaging, image-guided therapy, patient monitoring and health informatics, consumer health and home care solutions.

With around 77,000 employees, the company has sales and services in more than 100 countries.