Philips announces first U.S. patient enrolled in ILLUMENATE BTK IDE study
Royal Philips announced enrollment of the first U.S. patient in the Stellarex ILLUMENATE Below-the-Knee, or BTK, Investigational Device Exemption, or 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, or PTA, in patients with critical limb ischemia, or 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.