BD's Venovo Venous Stent Receives FDA Approval for Iliofemoral Obstructive Disease

VCBeat (WeChat ID: vcbeat) has learned that Venovo, a venous stent developed by BD (Becton, Dickinson and Company), a global leader in medical technology, has recently received approval from the U.S. Food and Drug Administration (FDA). This marks the first venous stent approved for the treatment of iliofemoral venous occlusive disease.

The Venovo venous stent is a flexible nitinol stent that restores blood flow in obstructed iliofemoral and femoral veins, thereby maintaining adequate perfusion. Available in multiple sizes, the stent exhibits excellent radial strength and flexibility. Michael Dake, the principal investigator for Venovo, stated, “The unique attributes of Venovo are particularly well-suited for treating iliofemoral occlusive disease. Notably, this stent is specifically designed for venous interventions to address venous pathology.”

BD conducted a one-year clinical trial involving 170 patients with iliofemoral venous occlusive disease. The results demonstrated that Venovo is safe and effective for the treatment of this condition. The patency rate was 96.9% in patients with non-thrombotic lesions and 81.3% in those with post-thrombotic lesions. Patients reported that treatment with Venovo reduced their pain and improved their quality of life.

Iliofemoral Venous Occlusive Disease is a condition characterized by lower extremity venous insufficiency resulting from iliac vein stenosis or occlusion. Clinical manifestations include varicose veins of the lower extremities, leg swelling, trophic skin changes, venous claudication, and venous ulcers. Venous stent implantation is the preferred treatment for iliofemoral venous occlusive disease, offering advantages such as minimal invasiveness, high procedural success rates, superior long-term patency, and low complication rates.

BD President Steve Williamson stated, “The FDA approval of Venovo represents a significant advancement in the treatment of iliofemoral venous occlusive disease. This condition is challenging to manage, and clinicians can now use Venovo to treat both post-thrombotic and non-thrombotic lesions.”

BD stated that Venovo has been launched in the United States, Argentina, Australia, Brazil, Egypt, India, Israel, Mexico, Russia, Saudi Arabia, Singapore, Taiwan (China), and Europe.

Becton, Dickinson and Company (BD), founded in 1906 and headquartered in New Jersey, USA, is one of the world’s largest medical technology and medical device companies. It is dedicated to advancing global health by improving methods for medical discovery, enhancing the accuracy of medical diagnostics, and elevating the quality of care. The company provides innovative solutions to help advance cytology and genomics research, strengthen the diagnosis of infectious diseases and cancer, improve medication management, supply tools for surgical and interventional procedures, and support diabetes management, among other areas. BD operates in more than 50 countries and employs over 45,000 people worldwide.

(Compiled by Jiao Yanli)