Philips begins US clinical trial for dual laser-based PAD therapy

12 Nov 2024

Platform combining two treatments for peripheral artery disease should improve patient outcomes.

Healthcare developer Philips has announced the commencement of a US clinical trial for a new treatment of peripheral artery disease (PAD).

Characterized by a narrowing of the arteries supplying blood to the arms or legs, PAD usually stems from a build-up of fatty deposits in the arteries causing atherosclerosis.

Photonics-based treatments for PAD have been based around the use of lasers to ablate the obstructions within the arteries and restore blood flow, as a less invasive alternative to either bypass surgery or interventions with a stent.

Excimer lasers have been particularly suitable for this task, as in the platform developed by Israel's Eximo Medical using a 355-nanometer source to treat a number of vascular conditions, described at the time as a transformative laser technology to address unmet clinical needs.

Philips has now developed a device intended to integrate two forms of laser-based PAD therapy, atherectomy and intravascular lithotripsy, into a single clinical platform.

Atherectomy is the endoscopic technique by which artery blockages and plaque are irradiated with UV light to ablate the material, while intravascular lithotripsy involves calcified deposits being subjected to acoustic pressure waves, so as to fracture the obstruction and break up an blockage.

The latter method has become established for renal conditions, but the Philips team is now bringing it to PAD as a treatment for arterial disease. Combining the two methods in one platform will simplify workflows, potentially reduce the risks and improve outcomes for patients who might otherwise face multiple complex interventions, according to Philips.

The potential to revolutionize treatment of patients

"The unique and highly innovative feature of the Philips catheter is that both the atherectomy and lithotripsy are laser-driven," noted the developers.

"Compared to conventional intravascular lithotripsy devices, which require the use of a separate ultrasound catheter to create calcium-disrupting sonic shock waves, the Philips device uses a pulsed laser to instantly vaporize fluid within the blood vessel and create bubbles that expand and then rapidly collapse, generating the required sonic waves as they do so."

The first case using the new laser catheter took place at the Cardiovascular Institute of the South in Louisiana, successfully treating a 78-year-old male with peripheral vascular disease. The clinical trial will now continue, enrolling up to 155 patients at up to 30 sites to assess how this combined approach can optimize procedural efficiency and benefit patients.

"This innovative approach to vessel preparation could improve patient outcomes while minimizing the need for multiple therapies and interventions," commented Elizabeth Genovese from the Hospital of the University of Pennsylvania in Philadelphia, co-principal investigator of the trial.

"That makes this an exciting innovation milestone as we enroll the first patient in this important US clinical trial. 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."