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Nov 05, 2024

Philips launches PAD treatment device trial

November 4, 2024 By Danielle Kirsh The Cardiovascular Institute of the South in Louisiana used the device to treat a 78-year-old male patient with PAD, marking a significant step in advancing PAD

November 4, 2024 By Danielle Kirsh

The Cardiovascular Institute of the South in Louisiana used the device to treat a 78-year-old male patient with PAD, marking a significant step in advancing PAD care. This first procedure marks the launch of the company’s THOR IDE study.

“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.”

PAD affects millions of people globally, Philips said. It leads to reduced blood flow in the limbs and results in pain, ulcers and sometimes amputations. Traditional treatments for PAD typically require multiple steps and devices, increasing procedural complexity and risk.

The Philips laser catheter simplifies the process by combining two critical PAD treatments—laser-driven atherectomy to remove plaque and intravascular lithotripsy to modify or disrupt calcium deposits. Unlike conventional methods, Philips’ device creates sonic shockwaves using a pulsed laser, eliminating the need for separate ultrasound devices.

“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. Philips is dedicated to clinically validating its innovations through rigorous trials and does so in collaboration with strong clinical partners,” said Stacy Beske, business leader for Philips Image Guided Therapy Devices.

Philips’ THOR IDE clinical study is now underway, and the first U.S. patient has been enrolled. The study will assess the device’s safety and efficacy in a single-arm, multicenter study involving up to 155 patients across 30 sites in the U.S.

The study will focus on achieving successful outcomes with minimal complications. The primary endpoints include freedom from major adverse events such as mortality, unplanned amputations, clinically driven target lesion revascularization within 30 days of the procedure, and achieving less than or equal to 50% residual stenosis post-procedure. Patients will be following for 12 months.

“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.”

This laser-based PAD treatment system by Philips is currently investigational and not commercially available.

Filed Under: Cardiovascular Tagged With: Philips