Philips’ Duo Venous Stent System Launched to Treat Symptomatic Venous Outflow Obstruction

June 12, 2024—Royal Philips announced the first implantation of the Duo venous stent system. Duo, which has received FDA premarket approval (PMA), is indicated to treat symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI).

Developed by Vesper Medical, Inc., a wholly owned subsidiary of Philips, the Duo venous stent system is being marketed under the Philips brand.

Philips reported that the first commercial procedure was performed by Erin Murphy, MD, a vascular surgeon and Director of the Venous and Lymphatic Program at the Sanger Heart & Vascular Institute, Atrium Health, in Charlotte, North Carolina.

Data from the VIVID study supported FDA approval. VIVID, which is now in 36-month follow-up, transitioned upon FDA PMA from an investigational device exemption study to a postapproval study.

VIVID is evaluating the safety and efficacy of the Duo system in the treatment of nonmalignant iliofemoral occlusive disease. Conducted in the United States and Poland, VIVID enrolled 162 patients at 30 centers with three patient populations—nonthrombotic iliac vein lesion; postthrombotic syndrome; and acute deep vein thrombosis. The study mandated the use of intravascular ultrasound (IVUS) to aid in lesion assessment and stent sizing before device implantation.

The company stated that the study met all its primary safety and efficacy performance goals. The 12-month effectiveness endpoint for primary patency reached 90.2%, which exceeded the performance target goal of 77.3%. The 12-month primary safety endpoint of 98.7% exceeded the corresponding performance goal of 89%. In addition, quality-of-life and venous functional assessments that were performed in the VIVID study showed sustained improvements compared to baseline at 12 months.

Principal investigator Mahmood Razavi, MD, stated in the press release, “The VIVID study’s 12-month results demonstrate the safety and efficacy of the Duo venous stent system in the treatment of CVI, a vascular condition affecting millions of people worldwide.

“Duo represents a meaningful addition to the tools that clinicians can use to treat CVI patients, especially when used in conjunction with IVUS. Ultimately, the new device promises to enable excellent clinical outcomes and drive significant quality of life improvements.”