Philips Initiates U.S. Clinical Trial for Integrated Laser Atherectomy and Lithotripsy Device in PAD
核心洞察
Philips has enrolled the first patient in the U.S. THOR IDE clinical trial to evaluate its novel integrated laser atherectomy and intravascular lithotripsy device for treating peripheral artery disease (搜索) (PAD (搜索)).
The single-device system aims to simplify PAD (搜索) treatment by combining atherectomy and lithotripsy into one procedure, potentially reducing risks and improving outcomes for patients with calcified lesions.
The prospective, multicenter study will enroll up to 155 patients across 30 U.S. sites to assess the device's safety and efficacy, with a primary endpoint of freedom from major adverse events at 30 days.
Philips has announced the enrollment of the first patient in the U.S. THOR IDE clinical trial, evaluating a novel integrated laser atherectomy and intravascular lithotripsy catheter for the treatment of peripheral artery disease (搜索) (PAD (搜索)). This innovative device combines two critical PAD treatments into a single system, potentially streamlining procedures and improving patient outcomes.
The Cardiovascular Institute of the South in Louisiana successfully treated the first patient, a 78-year-old male with peripheral vascular disease, using the Philips laser catheter. The trial aims to gather clinical evidence supporting the adoption of this technology for treating challenging calcified lesions.
Simplifying Complex PAD Treatment
PAD (搜索) affects millions worldwide, particularly older adults and those with diabetes (搜索) or high cholesterol, leading to reduced blood flow to the limbs and potentially severe complications, including amputation. Calcified lesions pose a significant challenge, often requiring multiple treatment steps and devices.
The Philips laser catheter integrates atherectomy, which removes atherosclerotic plaque, and intravascular lithotripsy, which modifies calcium deposits. Unlike conventional lithotripsy devices that use separate ultrasound catheters, the Philips device uses a pulsed laser to vaporize fluid, creating sonic waves that disrupt calcium deposits.
THOR IDE Trial Details
The prospective, single-arm, multicenter study will enroll up to 155 patients at up to 30 sites in the U.S. under an Investigational Device Exemption (IDE) from the FDA. The 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, and achieving ≤50% residual stenosis post-procedure. Patients will be followed for 12 months.
According to 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, this approach could improve patient outcomes by minimizing the need for multiple therapies and interventions, potentially revolutionizing the treatment of patients with complex femoropopliteal lesions associated with moderate to severe calcifications.
Stacy Beske, Business Leader, Philips Image Guided Therapy Devices, stated that the combined laser atherectomy and intravascular lithotripsy device reflects Philips’ commitment to providing physicians with the tools needed to tackle complex vascular challenges more efficiently and effectively, potentially transforming treatment paradigms for peripheral artery disease (搜索). The Philips laser atherectomy and intravascular lithotripsy system is currently investigational and not yet commercially available.