Sonablate announced the first patient enrolment in its HIFIVE U.S. clinical trial, which is testing high-intensity focused ultrasound (HIFU) for the noninvasive treatment of incompetent veins.
Dr. Naiem Nassiri, MD, principal investigator and vascular surgeon at The Vascular Care Group, successfully performed the initial procedure, using the Sonablate probe to target a symptomatic, incompetent great saphenous vein.
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The HIFIVE trial is an FDA-approved, industry-sponsored Investigational Device Exemption (IDE) study conducted by Vascular Breakthroughs Research, an affiliate of The Vascular Care Group. It aims to assess the efficacy of Sonablate’s HIFU technology in treating incompetent peripheral veins. These veins, including refluxing superficial veins, disrupt normal venous flow and are often associated with chronic venous insufficiency (CVI).
“This is an exciting moment,” said Nassiri. “High intensity focused ultrasound, or HIFU, has the potential to be a non-invasive treatment option in the specialty of vascular surgery. This is the first, in-human use of the Sonablate probe globally for treating vascular malformations.”
The Sonablate HIFU system ablates incompetent peripheral veins, offering an alternative to invasive treatments that typically require needle penetration, catheter insertion and extensive anesthetic preparations. Unlike these procedures, HIFU is an extracorporeal method, delivering therapeutic ultrasound energy externally without instruments entering the body.
“This achievement represents the culmination of years of research and development,” said Naren Sanghvi, Chief Science Officer of Sonablate. “We are excited to introduce our innovative solutions to the vascular community, empowering these specialists with tools that can lead to faster recovery times and improved patient safety.”
The HIFIVE trial, listed under ClinicalTrials.gov ID NCT06642051, aims to evaluate Sonablate’s HIFU system’s efficacy and safety in vascular applications, potentially expanding the technology’s applications beyond prostate treatment to provide a non-invasive option for vascular patients.
“We are committed to leading the charge in medical innovation,” said Richard Yang, CEO of Sonablate. “We already have years of experience in using HIFU to treat certain conditions of the prostate, and we are excited to continue collaborating with healthcare providers to drive advancements that benefit patients and practitioners alike.”
