Philips has announced the enrollment of the first patient in the U.S. THOR IDE clinical trial, marking a significant step forward in the treatment of peripheral artery disease (PAD). The trial will assess a novel catheter that combines laser atherectomy and intravascular lithotripsy into a single device, streamlining PAD treatment. The first procedure using this device was successfully performed at the Cardiovascular Institute of the South in Louisiana, on a 78-year-old male with peripheral vascular disease.
Streamlining PAD Treatment
The innovative Philips laser catheter integrates two essential PAD treatments into one device: atherectomy, which removes plaque from the artery's inner surface, and intravascular lithotripsy, which modifies calcium deposits within the artery wall. Uniquely, both functions are laser-driven. Unlike conventional lithotripsy devices that use a separate ultrasound catheter, the Philips device uses a pulsed laser to vaporize fluid, creating bubbles that generate sonic waves to disrupt calcium.
The THOR IDE Clinical Trial
The prospective, single-arm, multicenter study 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 trial will evaluate the system's safety and effectiveness in achieving procedural success while minimizing complications. 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 post-procedure, as well as achieving ≤50% residual stenosis.
Expert Perspectives
Drs. Craig Walker and McCall Walker of Cardiovascular Institute of the South emphasized the importance of clinical evidence in adopting new technologies like the Philips system, stating, "This trial will provide essential data to demonstrate how this combined approach can optimize procedural efficiency and patient outcomes in treating challenging calcified lesions."
Dr. Genovese, vascular surgeon and co-principal investigator of the THOR trial at the Penn Advanced Limb Preservation, Hospital of the University of Pennsylvania, noted the potential of this integrated approach to "revolutionize the treatment of patients with complex femoropopliteal lesions associated with moderate to severe calcifications."
Addressing a Critical Need
PAD affects millions worldwide, particularly older adults and those with diabetes or high cholesterol, leading to reduced blood flow, pain, ulcers, and potential amputation. Calcified lesions pose a significant challenge, often requiring multiple procedures and devices. The Philips device aims to simplify this process, potentially improving outcomes and reducing the need for multiple interventions.
Stacy Beske, Business Leader, Philips Image Guided Therapy Devices, stated, "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."
