Philips Enrolls First U.S. Patient in ILLUMENATE BTK IDE Study Evaluating Stellarex Drug-Coated Balloon for Below-the-Knee Peripheral Artery Disease

VCBeat (WeChat: vcbeat) has learned that on November 12, 2018, U.S. local time, Royal Philips (NYSE: PHG; AEX: PHIA), a global leader in health technology, announced the enrollment of the first U.S. patient into the Stellarex Below-the-Knee (BTK) Investigational Device Exemption (IDE) study, led by Dr. Bill Gray and Dr. Mahmood K. Razavi. This unique, global, prospective, randomized, multicenter clinical trial aims to evaluate the safety and efficacy of the Stellarex 0.014 drug-coated balloon versus percutaneous transluminal angioplasty (PTA) in the treatment of patients with critical limb ischemia (CLI).

Over the next 12 to 18 months, the trial will enroll 354 patients across 45 sites in the United States, Europe, China, and Australia. The first patient enrolled in the United States was under the care of Dr. Craig Walker at the Cardiovascular Institute of the South in Houma, Louisiana.

Image source: Compelo website

Stellarex 0.014 OTW Drug-Coated Balloon is a product launched by Philips designed to maintain and restore blood flow in patients with peripheral artery disease (PAD). The product has currently received CE marking certification and is marketed in Europe.

Dr. Mahmood K. Razavi, Principal Investigator of the ILLUMENATE BTK trial, stated: “This study will continue to demonstrate the safety and durability benefits of the Stellarex 0.014 drug-coated balloon in patients with below-the-knee (BTK) peripheral artery disease (PAD). Given the challenging chronic nature of BTK PAD, we aim to validate that sustained therapy with Stellarex can reduce target lesion revascularization and amputation rates in patients.”

Peripheral artery disease (PAD) is a common condition in the United States, with reports indicating approximately 250 million PAD patients worldwide. If not treated promptly, this disease can lead to chronic limb-threatening ischemia (CLTI). Limb ischemia associated with lesions below the knee often involves long segments of calcification. Elderly patients with this condition typically have a poor prognosis, accompanied by severe complications and limited life expectancy. Therefore, endovascular treatment of CLTI remains a challenge for physicians.

It is reported that there are approximately 160,000 to 180,000 amputation procedures performed annually in the United States, with more than 50% of cases having undergone no diagnostic or therapeutic endovascular interventions in the year preceding amputation.

“With Stellarex BTK, we have the potential to improve patient outcomes and reduce readmission costs for patients with this complex condition, while providing clinicians with the necessary tools to help determine the right treatment approach for their patients,” said Christopher Barys, Head of Philips’ Image-Guided Therapy business.

Royal Philips (NYSE: PHG, AEX: PHIA), headquartered in the Netherlands, is a leading health technology company dedicated to improving people’s health and enabling better outcomes across the entire healthcare continuum, including healthy living, prevention, diagnosis, treatment, and home care. The company reported sales of €17.8 billion in 2017.