Philips has announced the enrollment of the first patient in the U.S. THOR IDE clinical trial, evaluating a novel integrated single-device system for the treatment of peripheral artery disease (PAD). This innovative device combines laser atherectomy and intravascular lithotripsy into a single catheter, potentially streamlining treatment and improving outcomes for PAD patients. The first procedure using the device was successfully performed at the Cardiovascular Institute of the South in Louisiana, marking a significant step forward in PAD treatment.
Streamlining PAD Treatment with Integrated Technology
The Philips laser catheter integrates two critical PAD treatments into one device: atherectomy to remove plaque and intravascular lithotripsy to modify calcium deposits. This eliminates the need for multiple devices and procedures, simplifying the treatment workflow. The device utilizes a pulsed laser to vaporize fluid within the blood vessel, creating bubbles that generate sonic waves to disrupt calcium deposits, differing from conventional lithotripsy devices that use separate ultrasound catheters.
THOR IDE Clinical Trial Details
The THOR IDE trial is a prospective, single-arm, multicenter study that will enroll up to 155 patients at up to 30 sites in the U.S. The trial, conducted under an Investigational Device Exemption (IDE) from the FDA, aims to evaluate the safety and effectiveness of the device in achieving procedural success with a low rate of 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, as well as achieving ≤50% residual stenosis post-procedure. Patients will be followed for 12 months.
Addressing a Critical Need in PAD Treatment
PAD affects millions worldwide, particularly older adults and those with diabetes or high cholesterol, leading to reduced blood flow to the limbs and potential amputation. Calcified lesions pose a significant challenge in PAD treatment, often requiring multiple steps and devices. The Philips device aims to address this challenge by simplifying the treatment process and potentially improving patient outcomes.
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 laser system. 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 improve patient outcomes and minimize the need for multiple interventions. Stacy Beske, Business Leader at Philips, highlighted the company's commitment to providing physicians with tools to tackle complex vascular challenges efficiently.
