Philips’ THOR IDE Clinical Trial Underway

Royal Philips has enrolled the first patient in the U.S. THOR IDE clinical trial, which will study the company’s combined laser atherectomy and intravascular lithotripsy catheter that integrates two critical peripheral artery disease (PAD) treatments into a single device. Procedures that previously required the use of two different devices can now be performed in a single surgery with one 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 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.”

The first procedure not only marks the THOR IDE trial’s launch but also showcases the ways in which this new technology, developed in-house by Philips, can streamline complex interventions into a single procedure, possibly reducing the need for multiple surgical interventions and hospital visits.

The pivotal study will evaluate the safety and efficacy of Philips’ laser catheter, which integrates laser atherectomy and intravascular lithotripsy in a single device to treat complex, calcified lesions in a single procedure and restore blood flow to PAD patients’ legs.

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.

“This 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, a vascular surgeon and co-principal THOR trial investigator 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 catheter integrates two critical PAD treatments into a single device, significantly simplifying the treatment workflow—atherectomy to remove atherosclerotic plaque from the internal surface of an artery, and intravascular lithotripsy to modify calcium deposits within the artery or disrupt calcium deposits in the artery wall. The unique feature of the Philips catheter is that both the atherectomy and lithotripsy are laser-driven. Compared to conventional intravascular lithotripsy devices, which require the use of a separate ultrasound catheter to create calcium-disrupting sonic shockwaves, the Philips device uses a pulsed laser to instantly vaporize fluid within the blood vessel to create bubbles that expand and then rapidly collapse, generating the required sonic waves as they do so.

The THOR IDE Trial

The prospective, single-arm, multicenter study will enroll up to 155 patients at up to 30 U.S. sites. 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 complication rate.

The study’s 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 (about four and a half weeks) of the procedure, as well as achieving less than or equal to 50% residual stenosis post-procedure. Patients will be followed for 12 months.

“A result of Philips’ extensive in-house innovation and development capabilities, our combined laser atherectomy and intravascular lithotripsy device reflects our commitment to providing physicians with the tools they need to tackle complex vascular challenges more efficiently and effectively, potentially transforming treatment paradigms for peripheral artery disease,” stated Stacy Beske, business leader of Philips Image Guided Therapy Devices. “Philips is dedicated to clinically validating its innovations through rigorous trials and does so in collaboration with strong clinical partners.”

The Philips laser atherectomy and intravascular lithotripsy system is currently investigational and not commercially available.

Reference
¹ Peripheral artery disease (PAD) – Symptoms and causes – Mayo Clinic