Charlotte, NC – Sonablate Corp., current makers of the Sonablate HIFU system for prostate tissue ablation, today announced the first patient enrolled in the HIFIVE U.S. clinical trial under the vision, oversight, and guidance of principal investigator, Dr. Naiem Nassiri, MD – a vascular surgeon with The Vascular Care Group. As part of this new trial, effective HIFU delivery to a symptomatic, incompetent great saphenous vein was safely performed by Dr. Nassiri at The Vascular Care Group in Darien, CT using the Sonablate probe. The clinical trial, which is an FDA-approved, Industry-sponsored Investigational Device Exemption trial (NCT06642051), is being overseen and conducted by Vascular Breakthroughs Research, an affiliate of The Vascular Care Group.
"This is an exciting moment," said Dr. 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 US 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 anesthetic 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 Dr. 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, 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.”
For more information about Sonablate and its innovative medical technologies, please visit www.sonablate.com.
About Sonablate
Sonablate Corp. is a world leader in non-invasive, focused ultrasound technologies, and it is committed to developing medical devices that support precise and innovative procedures for the treatment of a range of medical conditions. For prostate tissue ablation, Sonablate Corp. currently designs and manufactures the Sonablate® HIFU device, which has 510(K) clearance in the U.S, NMPA clearance in China, and CE Marking in the EU, and which has obtained regulatory authorization in more than 50 additional countries.
About The Vascular Care Group
The Vascular Care Group is the largest independent vascular surgery practice in the U.S., specializing in the diagnosis, treatment, and management of vascular conditions. With eight full-service vascular centers across New England and led by a team of highly skilled vascular surgeons, the group provides expertise in the full spectrum of vascular diseases, including peripheral artery disease (PAD), venous insufficiency, aneurysms, and vascular malformations. Dedicated to employing minimally invasive techniques whenever possible, they aim to reduce recovery times and improve patient outcomes. Their commitment to advancing vascular medicine through research and education highlights their dedication to both improving patient care and advancing the field.
About Vascular Breakthroughs
Vascular Breakthroughs is a leading research and clinical trials management company dedicated to enabling physicians in independent practice to participate in cutting-edge research. Founded in 2012 by Dr. Paul J. Gagne, a vascular surgeon and internationally recognized expert in venous disease, Vascular Breakthroughs has played a key role in bringing innovative technologies to physicians in the community. This effort has improved access to novel treatments for patients and provided industry leaders and early-stage organizations the opportunity to evaluate new therapies in a safe, efficient manner. Since its inception, Vascular Breakthroughs has managed dozens of clinical trials and currently oversees more than 20 active trials.
For additional information or to schedule an interview, please email info@sonablate.com
Sonablate® HIFU is approved in more than 50 countries worldwide and was the first focused ultrasound device to be FDA-cleared in the U.S. for the ablation of prostate tissue. This innovative solution for prostate diseases has allowed Sonablate® HIFU to become the industry leader in focal therapy. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Sonablate is a registered trademark of Sonablate Corp. © 2023 Sonablate Corp. All rights reserved.
