Wearable Ultrasound Non-Invasively Treats Chronic Limb-Threatening Ischemia

Peripheral arterial disease (PAD) is a condition affecting millions globally, where peripheral arteries become narrowed, restricting blood flow from the heart to other body parts. PAD patients with extreme blockages can progress to Chronic Limb-Threatening Ischemia (CLTI), experiencing severe pain, non-healing sores, and wounds, often leading to limb amputation. Now, a novel, non-invasive, wearable therapeutic ultrasound device designed to treat CLTI and PAD can improve tissue perfusion, reduce symptoms, and save limbs.

Vibrato Medical (Newport Beach, CA, USA) is developing the first wearable therapeutic ultrasound device designed to promote vasodilation and vessel growth. Based on decades of therapeutic ultrasound research and the latest technological advancements, Vibrato’s technology is the first wearable therapeutic ultrasound device designed to promote vasodilation and vessel growth. Unlike endovascular and surgical revascularization, Vibrato’s technology can be applied without a single skin incision. Therapeutic ultrasound, the scientific basis of Vibrato’s approach, has been validated through animal and clinical studies that found it demonstrated vasodilation, collateral vessel growth, and angiogenesis.

Image: The technology is the first wearable therapeutic ultrasound designed to promote vasodilation and vessel growth (Photo courtesy of Vibrato Medical)

Vibrato has now announced that data from an early feasibility study of non-invasive therapeutic ultrasound (TUS) to treat CLTI has successfully met its endpoint. The study evaluated patients with infrapopliteal PAD and measured changes in foot perfusion and oxygenation as well as therapy tolerance, compliance, and perception. Participants, categorized as having Rutherford class 3, 4, or 5 PAD, underwent 30-40 TUS treatment sessions over two months. Remarkably, each participant exhibited statistically significant improvements in perfusion post-treatment, demonstrating the potential of this device to revolutionize treatment for individuals suffering from severe PAD and CLTI.

“These early findings are promising for the future of non-invasive therapeutic options to treat chronic limb-threatening ischemia,” said Juliana Elstad, CEO at Vibrato. “We’re looking forward to building on these findings as we begin our next prospective multi-center randomized clinical trial.”

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