Dutch medtech giant Philips has announced that it has enrolled the first patient in its THOR IDE clinical trial set to study the company’s combined laser atherectomy and intravascular lithotripsy catheter designed for the treatment of peripheral artery disease (PAD).
The company claims that the combination technology procedures that previously required the use of two different devices can now be performed in a single procedure using a single device, cutting down on hospitalisations and cost. Carried out at the Cardiovascular Institute of the South in Louisiana, the initial test saw clinicians treating a 78-year-old male with peripheral vascular disease.
The prospective, single-arm, multicentre study is set to enrol 155 patients across 30 sites throughout the US, conducted under an Investigational Device Exemption (IDE) previously awarded to the company by the US Food and Drug Administration (FDA).
Primary study endpoints include avoiding major adverse events such as mortality, unplanned amputations, and clinically driven target lesion revascularisation within 30 days of the procedure.
Research conducted by the US National Institutes of Health (NIH) found that PAD affects approximately 8 to 12 million people across the country, mostly over the age of 50. GlobalData epidemiologists estimate there were 18,386,656 diagnosed prevalent cases of PAD globally in 2023, which are expected to grow to 18,751,586 cases by this year.
Elizabeth Genovese, co-principal investigator of the THOR trial, said: “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 enrol the first patient in this important U.S. 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.”
The move for the beleaguered medical device company comes after its respiratory department was hit with yet another recall notice by the FDA after it was found that the software in some of its ventilators was liable to show inaccurate readings causing false power loss.
Stacy Beske, business leader for Philips Image Guided Therapy Devices, added: “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.”
Elsewhere in the PAD market, US bioabsorbable scaffold company, R3 Vascular, has announced that it has been granted IDE approval from the US FDA to launch its ELITE-BTK pivotal trial.
