Royal Philips has enrolled the first patient in a clinical trial to evaluate a new device combining laser atherectomy and intravascular lithotripsy for the treatment of peripheral artery disease (PAD).
The THOR IDE trial will assess the system’s ability to streamline complex PAD procedures that typically require multiple devices, potentially improving patient outcomes and reducing the need for multiple interventions.
The Cardiovascular Institute of the South in Louisiana successfully performed the trial’s first procedure on a 78-year-old male with peripheral vascular disease. Researchers at the institute are hopeful that further treatments will provide essential data to demonstrate how this combined approach can optimize procedural efficiency and patient outcomes in treating challenging calcified lesions.
The prospective, single-arm study will enroll up to 155 patients across 30 U.S. sites, under an Investigational Device Exemption from the FDA. Researchers will monitor primary endpoints, including freedom from major adverse events and achievement of residual stenosis of 50% or less within 30 days post-procedure, with a follow-up period of 12 months.
PAD, which affects millions globally, is marked by reduced blood flow to the limbs and is often worsened by calcified lesions that complicate treatment. Philips’ new catheter uses a laser-driven approach for both atherectomy, which removes plaque, and lithotripsy, which modifies or disrupts calcium deposits. The device's laser pulses vaporize fluid to create bubbles that rapidly collapse, generating the sonic waves needed to treat calcified areas — a process that traditionally requires a separate ultrasound catheter.
“This innovative approach to vessel preparation could improve patient outcomes while minimizing the need for multiple therapies and interventions. That makes this an exciting innovation milestone as we enroll the first patient in this important U.S. clinical trial,” said Dr. Genovese, 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.”
