Philips has announced the enrollment of the first patient in the U.S. clinical trial for its innovative single-device system designed to treat peripheral artery disease (PAD). The system integrates laser atherectomy and intravascular lithotripsy into a single device, aiming to improve patient outcomes and streamline treatment for complex vascular conditions.
The prospective, single-arm, multicenter THOR trial will enroll up to 155 patients across approximately 30 sites in the U.S. Conducted under an Investigational Device Exemption (IDE) from the FDA, the study will evaluate the safety and effectiveness of the system in achieving procedural success with a low rate of complications. Patients will be followed for 12 months.
The trial's primary endpoints include freedom from major adverse events (MAEs) – such as mortality, unplanned amputations, and clinically driven target lesion revascularization (CD-TLR) – within 30 days of the procedure. An additional primary endpoint is achieving less than or equal to 50% residual stenosis post-procedure.
Expert Commentary
"This innovative approach to vessel preparation could improve patient outcomes while minimizing the need for multiple therapies and interventions," said Dr. Genovese, MD, vascular surgeon and co-principal investigator of the THOR trial at the Penn Advanced Limb Preservation, Hospital of the University of Pennsylvania. "Integrating atherectomy and intravascular lithotripsy into a single device has the potential to revolutionize the treatment of patients with complex femoropopliteal lesions associated with moderate to severe calcifications."
Device Innovation
Stacy Beske, Business Leader, Philips Image Guided Therapy Devices, stated, "A result of Philips’ extensive in-house innovation and development capabilities, our combined laser atherectomy and intravascular lithotripsy device reflects our commitment to providing physicians with the tools they need to tackle complex vascular challenges more efficiently and effectively, potentially transforming treatment paradigms for peripheral artery disease. Philips is dedicated to clinically validating its innovations through rigorous trials and does so in collaboration with strong clinical partners."
The Philips laser atherectomy and intravascular lithotripsy system is currently investigational and not yet commercially available worldwide, including in the United States.
