First and only peripheral deploy venous stent system for accuracy in landing peripheral stents in patients suffering from Post Thrombotic Syndrome associated with venous outflow obstruction
FREMONT, California and ST. LOUIS, April 21, 2016 /PRNewswire/ -- VENITI, Inc., the leader in the advancement of treatment for venous disease, announced today the successful treatment of the first patient suffering from Post Thrombotic Syndrome associated with venous outflow obstruction with the VICI VERTO VENOUS STENT System. This innovative stent delivery system allows the physician to deploy a venous stent beginning at the peripheral end of the common femoral vein. The stent system received CE Marking on April 1, 2016. The announcement comes ahead of next week's Charing Cross Symposium in London UK, where the company will preview the product, along with the already-released VICI VENOUS STENT®.
"Frequently, in patients with extensive venous outflow obstruction causing Post Thrombotic Syndrome, it is necessary to extend the stents below the inguinal ligament to cover the entirety of the common femoral vein. In these cases, accurate stent placement is essential to maintain inflow to the stent system from both the profunda and femoral veins," said Mr. Stephen Black, Consultant Vascular Surgeon, Guy's and St. Thomas' NHS Foundation Trust, London U.K., who performed the procedure. "It is encouraging to see the team at VENITI and others in industry working with physicians to develop new products like the VICI VERTO VENOUS STENT which address the specific needs of the physicians treating venous disease."
Post Thrombotic Syndrome is a complication of deep vein thrombosis, which affects more than 1.4 MM people across the United States and Western Europe each year1. It is estimated that 20-50% of the people who have had a deep vein thrombosis will develop Post Thrombotic Syndrome2. Post Thrombotic Syndrome can have devastating, long-term consequences affecting the quality of life for the thousands of people who suffer from the condition. Symptoms include progressive leg pain and swelling, leg heaviness and skin changes. Physicians treat the obstructive component of Post Thrombotic Syndrome through minimally-invasive endovascular stenting procedures. The VIRTUS Trial is being performed under a U.S. Food and Drug Administration Investigational Device Exemption to evaluate the safety and efficacy of the VICI VENOUS STENT for the treatment of chronic iliofemoral venous outflow obstruction.
"Completing our first case of the novel VICI VERTO VENOUS STENT System by Mr. Black is a very significant milestone for VENITI. This new concept, which is used to deliver and implant the VICI VENOUS STENT, is designed for accurate deployment at the lower or peripheral iliofemoral vein landing zones and is the first of its kind in our field," said Jeff Elkins, President and CEO of VENITI, Inc. "This technology represents a major step in advancing treatment options for vascular interventionalists who address the tremendous problem of venous outflow obstruction relating to Post Thrombotic Syndrome and highlights our dedication to advancing the treatment of venous disease overall."
About VENITI, Inc.
VENITI, Inc. is dedicated to advancing the treatment of venous disease through clinical research and innovative technology and solutions. VENITI partners with leading physicians in the development and training for therapies to care for the millions of patients suffering from venous disease. The VICI VENOUS STENT and VICI VERTO VENOUS STENT were developed specifically for the challenges of treating iliofemoral venous outflow obstruction. VENITI was founded in 2010 and is headquartered in St. Louis, MO, with technical operations in Fremont, CA. The VICI VENOUS STENT and VICI VERTO VENOUS STENT are CE marked under the European Medical Devices Directive (93/42/EEC) and commercially available in Europe. The VICI VENOUS STENT is approved by the Australian Therapeutic Goods Administration and commercially available in Australia. CAUTION: Investigational device. Limited by United States law to investigational use. The VICI VERTO VENOUS STENT is not approved for sale in the United States. VENITI and VICI VENOUS STENT are registered trademarks of VENITI, Inc. VICI VERTO VENOUS STENT is a trademark of VENITI, Inc. ©2016 VENITI, Inc. All Rights Reserved. Produced in the U.S. Learn more about VENITI and its products at www.veniti.com
- Roumen-Klappe EM, den Heijer M, Janssen MC, et al. The post-thrombotic syndrome: incidence and prognostic value of non-invasive venous examinations in a six-year follow-up study. Thromb Haemost. Oct 2005;94(4):825-830.
- Baldwin MJ, Moore HM, Rudarakanchana N, et al. Post-thrombotic syndrome: a clinical review. J Thromb Haemost. May 2013;11(5):795-805.
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