Philips enrolls first U.S. patient in trial for innovative single-device treatment for peripheral artery disease

Royal Philips , a global leader in health technology, today announced enrollment of the first patient in the U.S. THOR IDE clinical trial, which will study an innovative combined laser atherectomy and intravascular lithotripsy catheter developed by Philips, that integrates two critical PAD treatments into a single device. Procedures that previously required the use of two different devices can now be performed in a single procedure using a single device, simplifying workflows and procedures and potentially reducing the risk and improving outcomes for patients who might otherwise face multiple complex interventions.

The Cardiovascular Institute of the South in Louisiana recently completed the first case using the new laser catheter. The care team there successfully treated a 78-year-old male with peripheral vascular disease using the Philips device.

“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 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.”

This ground-breaking first procedure not only marks the launch of the THOR IDE trial. It also showcases how this innovative new technology, which resulted from Philips’ powerful in-house development capabilities, can ease the patient experience by streamlining complex interventions into a single procedure, potentially reducing the need for multiple interventions and hospital visits.

Significantly simplifying the treatment workflow
PAD is a common and serious condition that affects millions of people worldwide, particularly older adults and those with diabetes or high cholesterol. It leads to reduced blood flow to the limbs, often resulting in severe pain, ulcers, and, in extreme cases, limb amputation [1]. Patients with calcified lesions represent a particularly challenging group, as traditional treatment options often involve multiple steps and devices, increasing procedural complexity and risk.

Prospective, single-arm, multicenter study
The prospective, single-arm, multicenter study will enroll up to 155 patients at up to 30 sites in the U.S. Conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), it will assess the system's safety and effectiveness in achieving procedural success with a low rate of complications.

“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, MD, 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.”

The Philips laser atherectomy and intravascular lithotripsy system is currently investigational and not yet commercially available anywhere in the world, including the United States.