Royal Philips has announced the enrollment of the first patient in the U.S. THOR IDE clinical trial, a study designed to evaluate an innovative system that integrates laser atherectomy and intravascular lithotripsy into a single catheter for the treatment of peripheral artery disease (PAD). This integrated approach aims to streamline procedures, potentially reducing risks and improving outcomes for patients with complex, calcified lesions.
The first procedure was successfully performed at the Cardiovascular Institute of the South in Louisiana, where a 78-year-old male with peripheral vascular disease was treated using the Philips device. The integrated system allows physicians to perform procedures that previously required two separate devices in a single intervention.
Streamlining PAD Treatment with Integrated Technology
The Philips laser catheter uniquely combines atherectomy, which removes atherosclerotic plaque, and intravascular lithotripsy, which modifies calcium deposits within the artery. Both functions are laser-driven, with the lithotripsy utilizing a pulsed laser to create sonic waves that disrupt calcium deposits. This eliminates the need for a separate ultrasound catheter typically required in conventional intravascular lithotripsy devices.
THOR IDE Trial Details
The THOR IDE trial is a prospective, single-arm, multicenter study that plans to enroll up to 155 patients across approximately 30 sites in the U.S. The trial, conducted under an Investigational Device Exemption (IDE) from the FDA, will primarily assess the safety and effectiveness of the integrated system in achieving procedural success while minimizing complications. Patients will be followed for 12 months post-procedure.
The primary endpoints of the study include freedom from major adverse events (MAEs), such as mortality, unplanned amputations, and clinically driven target lesion revascularization (CD-TLR) within 30 days, as well as achieving less than or equal to 50% residual stenosis post-procedure.
Expert Perspectives
"Developing and driving clinical evidence is crucial to improving care and guiding the adoption of new technologies like the Philips laser atherectomy and lithotripsy system," said Drs. Craig Walker, Pradeep Nair, and McCall Walker of Cardiovascular Institute of the South in Louisiana. "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, MD, vascular surgeon and co-principal investigator of the THOR trial at the Penn Advanced Limb Preservation, Hospital of the University of Pennsylvania, added, "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."
The Philips laser atherectomy and intravascular lithotripsy system is currently for investigational use only and is not commercially available.
