Sonablate has announced the first patient enrolled in the HIFIVE clinical trial in the USA under the guidance of principal investigator, Naiem Nassiri (The Vascular Care Group, Darien, USA).
As part of this new trial, effective HIFU delivery to a symptomatic, incompetent great saphenous vein was safely performed by Nassiri using the Sonablate probe. The clinical trial, which is an US Food and Drug Administration (FDA)-approved, industry-sponsored investigational device exemption (IDE) trial is being overseen and conducted by Vascular Breakthroughs Research, an affiliate of The Vascular Care Group.
“This is an exciting moment,” said Nassiri. “High intensity focused ultrasound, or HIFU, has the potential to provide many benefits within the specialty of vascular surgery, and I’m proud to have foreseen and implemented this technology for an extracorporeal means of treating incompetent veins of the periphery. This is the first-in-human use of the Sonablate probe for this application and will be the first such application globally using this platform for treating vascular malformations.”
Incompetent veins include refluxing superficial veins of the periphery and include vascular malformations. They impact normal venous flow patterns and can lead to chronic venous insufficiency (CVI), a painful condition that currently affects millions of people in the USA and even more globally.
The Sonablate HIFU system is intended to be used in this study to ablate, or eliminate, incompetent veins of the periphery, which includes the legs, abdomen, chest or back. Typically, this condition is treated with invasive techniques such as needle penetration and wire or catheter insertions that require extensive and uncomfortable anaesthetic preparations of the targeted vein. But, HIFU is a completely extracorporeal, non-invasive approach, meaning that no part of the treating instrument probe enters the body for delivery of ultrasonic therapeutic energy.
“This achievement represents the culmination of years of research and development initiated by Nassiri,” 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.”
“We are committed to leading the charge in medical innovation,” said Richard Yang, chief executive officer 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.”
