Sonablate has announced the enrollment of the first patient in its HIFIVE (HIFU for Incompetent Vein Evaluation) U.S. clinical trial. This trial is designed to evaluate the safety and efficacy of high-intensity focused ultrasound (HIFU) for the non-invasive treatment of incompetent veins.
The initial procedure was successfully performed by Dr. Naiem Nassiri, a vascular surgeon at The Vascular Care Group and the trial's principal investigator. Dr. Nassiri utilized the Sonablate probe to target a symptomatic, incompetent great saphenous vein.
HIFIVE Trial Details
The HIFIVE trial (ClinicalTrials.gov ID: NCT06642051) is an FDA-approved, industry-sponsored Investigational Device Exemption (IDE) study conducted by Vascular Breakthroughs Research, an affiliate of The Vascular Care Group. The trial aims to determine the effectiveness of Sonablate’s HIFU technology in treating incompetent peripheral veins, including refluxing superficial veins associated with chronic venous insufficiency (CVI).
"This is an exciting moment," said Dr. 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."
How Sonablate HIFU Works
The Sonablate HIFU system ablates incompetent peripheral veins through an extracorporeal method. This approach delivers therapeutic ultrasound energy externally, eliminating the need for instruments to enter the body. This contrasts with traditional invasive treatments that typically require needle penetration, catheter insertion, and extensive anesthetic preparations.
Company Perspective
"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."
Richard Yang, CEO of Sonablate, added, "We are committed to leading the charge in medical innovation. 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."
