VENITI(TM), Inc. Announces FDA Approval of IDE for VENITI VICI(TM) Venous Stent System
First Patients Enrolled in VIRTUS Trial
ST. LOUIS, July 14, 2014 /PRNewswire/ — VENITI, Inc., a company dedicated to providing innovative technology for the treatment of venous disease, announced that it has received approval from the United States Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin the VIRTUS trial of the VENITI VICI Venous Stent System. The VICI Venous Stent System was designed from inception to be compatible with the unique anatomy and pathophysiology of the venous system. Hundreds of thousands of people around the world suffer from lower-extremity venous disease, and until recently, the only treatment options available involved the use of re-purposed vascular stents originally designed for use in the arterial system.
Co-Principal Investigators for the VIRTUS Trial are William Marston, M.D., Chief, Division of Vascular Surgery, Professor, Department of Surgery, UNC Department of Surgery, Chapel Hill, NC and Mahmood Razavi, M.D., Director for Clinical Trials & Research at the Heart and Vascular Center, St. Joseph Hospital, Orange, CA.
“Obstruction of the iliac veins and vena cava have been identified as a frequent cause of severe venous disease resulting in major disabling symptoms including leg swelling, pain, and ulceration,” said Dr. Marston. He added, “The development of stents specifically designed for the unique characteristics of the venous system provide the potential to reduce these debilitating symptoms for patients, while improving the cost effectiveness of interventional treatment for venous obstruction.”
Dr. Razavi commented, “This is an important landmark for VENITI and patients with deep venous disease. Due to the absence of vein-specific stents, physicians have thus far been using stents that were not designed for veins. We look forward to the completion of this important study and availability of optimal stents to treat our patients with deep vein obstructive lesions.”
The trial has commenced in Europe, with first patients enrolled and treated by Marta Ramirez Ortega, M.D. at Hospital Madrid Monteprincipe in Madrid, Spain. “It is important for my patients to be able to be treated with a stent specifically designed for the venous anatomy and for them to have their data collected so that future patients can benefit from knowing how well venous stenting works,” said Dr. Ramirez.
“We are very pleased with the approval of our IDE and excited to be conducting this important research with physicians in both Europe and the U.S.” said Scott Solano, VENITI President and Chief Executive Officer. “The unique advantages of a stent designed specifically for the venous system, including end-to-end crush resistance, flexibility, and continuous vein coverage, may offer significant patient benefit.”
About VENITI, Inc.
VENITI, Inc. is an early-stage commercialization company that is headquartered in St. Louis, MO and has established an innovation center for Research & Development and Operations in Fremont, CA. Founded in 2010, it is the first medical device company developing a suite of innovative technology and solutions that will provide comprehensive treatment across the venous disease continuum. The VENITI team of experts in science, technology and business are currently developing the VENITI VICI Venous Stent System, which is CE marked under the European Medical Devices Directive (93/42/EEC) and commercially available in Europe. CAUTION: Investigational device. Limited by United States law to investigational use. VENITI is also developing the VENITI VIDI(TM) Vena Cava Filter. CAUTION: Investigational device. Limited by United States law to investigational use. In launching its technologies, VENITI partners with individuals and companies with leadership roles in the development and training for therapies to provide advancement of care in venous disease. Through these, and other innovative technology, VENITI will achieve results that sets it apart in addressing the challenges specific to the venous system and venous disease. VENITI, VENITI VICI, VENITI VIDI are trademarks of VENITI, Inc. ©2014 VENITI, Inc. All Rights Reserved. Produced in the U.S. For more information, call +1 314 282 3753 or visit www.veniti.com.
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SOURCE VENITI, Inc.