Philips Announces First U.S. Patient Enrolled in ILLUMENATE Study of Stellarex 0.014 Drug-Coated Balloon for BTK PAD

November 12, 2018

Study will assess safety and effectiveness of treatment that restores adequate blood flow in legs of patients to reduce repeat revascularizations and amputations of major lower limbs

AMSTERDAM, Nov. 12, 2018 — Royal Philips announced enrollment of the first U.S. patient in the Stellarex ILLUMENATE Below-the-Knee (BTK) Investigational Device Exemption (IDE) study, led by principal investigators Dr. Bill Gray and Dr. Mahmood K. Razavi. This unique global, prospective, randomized, multi-center trial is designed to assess safety and effectiveness of the Stellarex 0.014 drug-coated balloon versus percutaneous transluminal angioplasty (PTA) in patients with critical limb ischemia (CLI). The trial will enroll 354 patients at 45 sites in U.S., Europe and Australia in the next 12-18 months. The first patient in the U.S. was enrolled by Dr. Craig Walker at the Cardiovascular Institute of the South in Houma, Louisiana.

"Several studies have shown the safety and durability benefits of the Stellarex balloon," said Mahmood K. Razavi, MD, FSIR, FSVM, St. Joseph's Hospital in Orange, CA and principal investigator of the ILLUMENATE BTK study. "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."

"Peripheral artery disease below the knee is challenging and Philips is committed to providing proven clinical solutions that positively impact patient outcomes," said Christopher Barys, Image Guided Therapy Devices Business Leader for Philips. "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."  

PAD is prevalent in the U.S. and affects around 250 million people worldwide [1]. If left untreated, the condition can lead to chronic limb ischemia (CLI). CLI associated with infrapopliteal arteries behind the knee often involves long calcified segments [2]. The prognosis is worse in elderly patients with severe comorbidities and limited life expectancy [3]. Therefore, the endovascular treatment of CLI remains a challenge for physicians. In the U.S., 160,000 – 180,000 amputations are performed annually, with more than 50 percent of cases having no diagnostic or therapeutic endovascular intervention performed in the year before an amputation [4].    

Philips' image-guided therapy solutions comprise interventional imaging systems, smart devices, software and services that enable clinicians to decide, guide, treat and confirm the appropriate cardiac and peripheral vascular treatment. By designing intelligent technologies and services that help clinicians to deliver a consistent standard of care, optimize care pathways and integrate workflows, Philips is enabling better patient and population outcomes.

The Stellarex 0.014" OTW Drug-Coated Balloon is designed to restore and maintain blood flow to arteries in patients with peripheral arterial disease. The Stellarex 0.014 Drug-Coated Balloon is CE Marked and available in Europe.

To find out more about Philips' image-guided therapy solutions visit us at VEITHsymposium in the Philips pavilion (Nassau Suites), taking place in New York, November 13-16.

[1] Shu J, Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis. 2018;275:379-381.
[2] Mustapha JA, Diaz-Sandoval LJ, Saab F. Infrapopliteal calcification patterns in critical limb ischemia: diagnostic, pathologic and therapeutic implications in the search for the endovascular holy grail. J Cardiovasc Surg 2017;58:383-401. DOI: 10.23736/S0021-9509.17.09878-0.
[3] Cardiovasc Intervent Radiol. 2018 Jan;41(1):1-20. doi: 10.1007/s00270-017-1796-9. Epub 2017 Sep 18. Predictive Parameters for Clinical Outcome in Patients with Critical Limb Ischemia Who Underwent Percutaneous Transluminal Angioplasty (PTA): A Systematic Review. Schreuder SM1, Hendrix YMGA2, Reekers JA2, Bipat S2.
[4] Sanguily III, J., Martinsen, B. J., Igyarto, Z., Pham,M.T.  Reducing Amputation Rates in Critical Limb Ischemia Patients Via a Limb Salvage Program: A Retrospective Analysis. Vascular Disease Management. 2016;13(5):E112-E119.