Michael Barbella, Managing Editor01.23.24
Data from Vibrato Medical's early feasibility study of Non-Invasive Therapeutic Ultrasound (TUS) to treat chronic limb-threatening ischemia (CLTI) has successfully met its endpoint. The study evaluated patients with infrapopliteal peripheral arterial disease (PAD) and measured changes in foot perfusion, oxygenation, therapy tolerance, compliance, and perception.
Patients in the 12-patient Prelude trial had Rutherford class 3, 4 or 5 peripheral arterial disease (PAD), meaning severe claudication, ischemic rest pain, or tissue loss, including nonhealing ulcers. The trial participants received 30-40 TUS treatment sessions over two months. At the end of the treatment:
More than 18 million people in the United States suffer from PAD, a disease that occurs when the peripheral arteries narrow, making it more challenging to carry blood away from the heart to other parts of the body.1 It is estimated that 2 million people with PAD have blockages so extreme they have advanced to CLTI, a chronic condition that can cause extreme pain, sores and wounds that do not heal and can result in the amputation of the affected limb.2 The unmet clinical needs for this population are extremely high.
“These early findings are promising for the future of non-invasive therapeutic options to treat chronic limb-threatening ischemia,” Vibrato Medical CEO Juliana Elstad stated. “We’re looking forward to building on these findings as we begin our next prospective multi-center randomized clinical trial.”
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.
Vibrato Medical is a private company located in Newport Beach, Calif., that has developed the first wearable therapeutic ultrasound device for the noninvasively treating peripheral arterial disease (PAD) and chronic limb-threatening ischemia (CLTI) in an outpatient setting. It is designed to promote vasodilation, collateral vessel growth, and angiogenesis, and restore perfusion. Its leadership team brings deep experience in developing and commercializing medical devices and is supported by an experienced board of directors as well as recognized clinical leaders in the PAD field.
References
1 The Sage Group. Critical Limb Ischemia. Volume 1 US Epidemiology, 2010. Accessed at http://thesagegroup.us/. October 14, 2016.
2 Duff, et al. Vascular Health and Risk Management 2019.
Patients in the 12-patient Prelude trial had Rutherford class 3, 4 or 5 peripheral arterial disease (PAD), meaning severe claudication, ischemic rest pain, or tissue loss, including nonhealing ulcers. The trial participants received 30-40 TUS treatment sessions over two months. At the end of the treatment:
- Each individual patient demonstrated a statistically significant improvement in perfusion
- Toe perfusion increased acutely by 180 ± 34% (p<0.001)
- Tissue oxygenation increased by +17% (p=.02)
- Patients showed excellent therapy tolerance, compliance, and feedback
More than 18 million people in the United States suffer from PAD, a disease that occurs when the peripheral arteries narrow, making it more challenging to carry blood away from the heart to other parts of the body.1 It is estimated that 2 million people with PAD have blockages so extreme they have advanced to CLTI, a chronic condition that can cause extreme pain, sores and wounds that do not heal and can result in the amputation of the affected limb.2 The unmet clinical needs for this population are extremely high.
“These early findings are promising for the future of non-invasive therapeutic options to treat chronic limb-threatening ischemia,” Vibrato Medical CEO Juliana Elstad stated. “We’re looking forward to building on these findings as we begin our next prospective multi-center randomized clinical trial.”
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.
Vibrato Medical is a private company located in Newport Beach, Calif., that has developed the first wearable therapeutic ultrasound device for the noninvasively treating peripheral arterial disease (PAD) and chronic limb-threatening ischemia (CLTI) in an outpatient setting. It is designed to promote vasodilation, collateral vessel growth, and angiogenesis, and restore perfusion. Its leadership team brings deep experience in developing and commercializing medical devices and is supported by an experienced board of directors as well as recognized clinical leaders in the PAD field.
References
1 The Sage Group. Critical Limb Ischemia. Volume 1 US Epidemiology, 2010. Accessed at http://thesagegroup.us/. October 14, 2016.
2 Duff, et al. Vascular Health and Risk Management 2019.