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DARIEN, Conn. - Hartok -- The Vascular Care Group (TVCG) announced that its Darien, Connecticut vascular center has enrolled the first patient in the nation in the FORTAVENA Post-Market Study, formally titled "The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study." The prospective, multicenter, single-arm study is designed to generate real-world clinical evidence on the safety and effectiveness of the GORE® VIABAHN® FORTEGRA Venous Stent, the first deep venous stent developed specifically to treat both symptomatic inferior vena cava (IVC) and iliac vein obstruction.
"Being first in the country to enroll a patient in this study is a tremendous honor for our team, and more importantly, a meaningful step forward for patients living with venous disease," said Dr. Chong Linus Li, MD, RPVI, a Board-certified vascular surgeon practicing at the Darien vascular center. "Studies like FORTAVENA help us build the real-world evidence demanded by the FDA and our patients in order to understand how this technology performs, so we can continue refining our approach and giving patients safer, more durable outcomes."
Many vascular conditions, such as deep venous disease, can be difficult to recognize because symptoms are often attributed to aging or other health conditions. Chronic leg pain, heaviness, skin damage, and swelling are typically unaddressed by patients and their doctors. In many cases, the underlying problem involves major veins such as the iliac and IVC, which are the primary pathways for returning blood from the lower body to the heart. When these vessels narrow or become obstructed, blood flow can be significantly impaired, leading to progressive pain and complications if left untreated. The GORE® VIABAHN® FORTEGRA Venous Stent is designed to treat this obstruction directly, and the FORTAVENA study will track how it performs in real-world use.
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TVCG's participation in FORTAVENA and other trials is supported by Vascular Breakthroughs, an affiliated clinical research organization that provides trial infrastructure, regulatory expertise, and data collection standards. That support allows TVCG physicians to take part in nationally significant studies while keeping enrollment close to home for patients across Massachusetts, Maine, and Connecticut.
TVCG's Darien, Connecticut office, located at 330 Boston Post Road, Suite 240, Darien, CT 06820, serves patients throughout Fairfield County and the surrounding Connecticut communities, offering a full range of minimally invasive diagnostic and treatment services for arterial and venous disease.
About The Vascular Care Group
The Vascular Care Group is one of the largest independent vascular surgery practices in the US, specializing in the diagnosis, treatment, and management of vascular conditions. Led by a team of highly skilled vascular surgeons practicing in Massachusetts, Maine, and Connecticut, The Vascular Care Group provides expertise across the full spectrum of vascular disease. Its commitment to advancing vascular medicine through research and education underscores its dedication to improving outcomes and advancing the field. For more information, visit https://thevascularcaregroup.com.
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About Vascular Breakthroughs
Vascular Breakthroughs was founded by Paul J. Gagne, MD, DFSVS, FACS, RVT, in 2012 to provide a research infrastructure for physicians not affiliated with an academic institution. The organization has put new technologies in the hands of physicians working in the community, thereby improving access to novel treatments for patients and expanding the reach of cutting-edge research. Vascular Breakthroughs provides administrative support for all aspects of clinical trial execution, including trial design and initiation, patient recruitment, and day-to-day trial management. More information is available at vascularbreakthroughs.com.
"Being first in the country to enroll a patient in this study is a tremendous honor for our team, and more importantly, a meaningful step forward for patients living with venous disease," said Dr. Chong Linus Li, MD, RPVI, a Board-certified vascular surgeon practicing at the Darien vascular center. "Studies like FORTAVENA help us build the real-world evidence demanded by the FDA and our patients in order to understand how this technology performs, so we can continue refining our approach and giving patients safer, more durable outcomes."
Many vascular conditions, such as deep venous disease, can be difficult to recognize because symptoms are often attributed to aging or other health conditions. Chronic leg pain, heaviness, skin damage, and swelling are typically unaddressed by patients and their doctors. In many cases, the underlying problem involves major veins such as the iliac and IVC, which are the primary pathways for returning blood from the lower body to the heart. When these vessels narrow or become obstructed, blood flow can be significantly impaired, leading to progressive pain and complications if left untreated. The GORE® VIABAHN® FORTEGRA Venous Stent is designed to treat this obstruction directly, and the FORTAVENA study will track how it performs in real-world use.
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TVCG's participation in FORTAVENA and other trials is supported by Vascular Breakthroughs, an affiliated clinical research organization that provides trial infrastructure, regulatory expertise, and data collection standards. That support allows TVCG physicians to take part in nationally significant studies while keeping enrollment close to home for patients across Massachusetts, Maine, and Connecticut.
TVCG's Darien, Connecticut office, located at 330 Boston Post Road, Suite 240, Darien, CT 06820, serves patients throughout Fairfield County and the surrounding Connecticut communities, offering a full range of minimally invasive diagnostic and treatment services for arterial and venous disease.
About The Vascular Care Group
The Vascular Care Group is one of the largest independent vascular surgery practices in the US, specializing in the diagnosis, treatment, and management of vascular conditions. Led by a team of highly skilled vascular surgeons practicing in Massachusetts, Maine, and Connecticut, The Vascular Care Group provides expertise across the full spectrum of vascular disease. Its commitment to advancing vascular medicine through research and education underscores its dedication to improving outcomes and advancing the field. For more information, visit https://thevascularcaregroup.com.
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About Vascular Breakthroughs
Vascular Breakthroughs was founded by Paul J. Gagne, MD, DFSVS, FACS, RVT, in 2012 to provide a research infrastructure for physicians not affiliated with an academic institution. The organization has put new technologies in the hands of physicians working in the community, thereby improving access to novel treatments for patients and expanding the reach of cutting-edge research. Vascular Breakthroughs provides administrative support for all aspects of clinical trial execution, including trial design and initiation, patient recruitment, and day-to-day trial management. More information is available at vascularbreakthroughs.com.
Source: The Vascular Care Group
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