Atrium Health Sanger Heart & Vascular Institute First in the World to Treat Patient with New Venous Stent System

Minimally invasive procedure offers hope to patients with debilitating condition

CHARLOTTE, N.C., June 18, 2024 – Atrium Health Sanger Heart & Vascular Institute has achieved a significant milestone in the treatment of chronic venous obstruction by becoming the first institution to successfully use the newly FDA-approved Duo venous stent system. This innovative, implantable medical device is designed to help patients with blocked veins by improving blood flow and reducing symptoms.

On June 11, Dr. Erin Murphy, a leading vascular surgeon and director of the venous and lymphatic program at Sanger Heart & Vascular Institute, performed the procedure in a new vascular catheterization lab at Atrium Health Pineville. Murphy, who played a pivotal role in the VIVID study leading to the device's FDA approval, successfully implanted the new venous stent system, marking a new chapter in the treatment of deep venous disease.

“Patients with this condition often experience severe pain, swelling and fatigue, which can significantly limit their daily activities and quality of life,” said Murphy. “The persistent symptoms and complications associated with venous occlusive disease can lead to substantial emotional and physical distress for patients.”

Chronic venous obstruction affects approximately 25 million people globally. It is a condition often resulting from venous thromboembolism – a blood clot formation in the veins. This disease is the third most common cardiovascular disorder and presents numerous complexities and mechanical challenges due to the unique demands of venous anatomy and obstructions.

This new venous stent system tackles the complex challenges of venous obstructions with its innovative dual-stent design. It includes two key parts: the hybrid and extend stents. The hybrid stent features a unique design with different zones that have specific mechanical properties, while the extend stent portion can be used alongside the hybrid for longer lesions. This system aims to lower the risk of stent fracture and corrosion, providing a reliable and flexible solution for managing venous obstructions.

“The innovative design of the system, with its ability to withstand the forces of compression and adapt to the curvature of the venous anatomy, addresses many of the limitations we faced with previous stents,” said Murphy. “This allows us to offer better outcomes for our patients suffering from this debilitating condition.”

The FDA approval of the Duo venous stent system is underpinned by the robust findings of the VIVID study – a global, prospective, multi-center clinical trial conducted in the United States and Poland. The study evaluated the safety and efficacy of the new venous stent system in treating nonmalignant iliofemoral occlusive disease across three patient populations: non-thrombotic iliac vein lesion (NIVL), post-thrombotic syndrome (PTS) and acute deep vein thrombosis (aDVT).

The VIVID study enrolled 162 subjects across 30 centers, including Sanger Heart & Vascular Institute, and achieved all its primary safety and efficacy performance goals. After 12 months, 90.2% of treated veins remained open and unobstructed, far surpassing the target goal of 77.3%. On the safety side, the stent system also performed exceptionally well, achieving a success rate of 98.7%, which significantly exceeded the goal of 89%.

The study assessed various aspects of quality of life and vein function, showing significant and sustained improvements for patients after 12 months. These improvements indicate that the treatment not only effectively addresses the medical condition but also enhances the overall well-being of the patients.

Sanger Heart & Vascular Institute remains a leader in vascular care, continuously achieving outstanding patient outcomes using advanced treatments and access to innovative clinical trials. With over 4,800 non-invasive intervention procedures performed since the program's inception, it has a remarkably low in-hospital mortality rate of 0.84%. Sanger’s dedication to improving patient care is further demonstrated by pioneering new procedures, including the venous stent system, as well as the first DETOUR procedure on the East Coast and the establishment of leading-edge facilities like a new vascular catheterization lab at Atrium Health Pineville.

“This milestone not only underscores our dedication to enhancing patient outcomes but also highlights our role as a leader in transforming cardiovascular care,” said Dr. Frank Arko, chief of vascular and endovascular surgery and co-director for the Center for Aortic Disease at Atrium Health Sanger Heart & Vascular Institute. “Through our ongoing efforts, we strive to improve the quality of life for patients dealing with vascular disease, reaffirming our position as a trusted name in advanced medical care.”