Philips Duo Venous Stent System for Iliofemoral Occlusive Disease Evaluated in VIVID Trial

October 30, 2023—The VIVID trial investigated the safety and efficacy of the Duo venous stent system (Philips) for the treatment of patients with nonmalignant iliofemoral occlusive disease. The Duo system, which is comprised of the Duo Hybrid and Duo Extend stents, is designed for the varying anatomical and mechanical demands of the iliofemoral venous segment.

VIVID was a prospective, multicenter, single-arm study that enrolled patients at 30 sites in the United States and Poland between 2020 and 2021. The trial was composed of 162 patients with nonthrombotic, acute thrombotic, or chronic post-thrombotic clinically significant venous outflow obstruction.

Patients were required to have at least one of the following clinical indicators: CEAP (clinical, etiology, anatomy, pathophysiology) ≥ 3, Venous Clinical Severity Score) ≥ 2, and/or suspected and symptomatic deep vein thrombosis.

The trial’s findings were presented by Mahmood Razavi, MD, at The VEINS (Venous Endovascular Interventional Strategies) annual venous education symposium held by The VIVA Foundation on October 28-30 in Las Vegas, Nevada.

According to The VEINS press release, performance goals for the study were established from published, peer-reviewed scientific literature.  

The primary endpoints, which were adjudicated by a clinical events committee and/or core laboratory, were the following:

•  The primary safety endpoint was freedom from major adverse events at 30 days postindex procedure.
• The primary efficacy endpoint was primary patency of the stented segment at 12 months. 

The primary efficacy performance goal was derived based on enrollment distribution within the three disease states.

Secondary and observational endpoints included symptom relief, primary-assisted patency, secondary-assisted patency, and device success.

The trial met its primary safety and efficacy endpoints, as follows:

• The primary safety endpoint of 30-day freedom from major adverse events was 98.7%.
• The primary efficacy endpoint of 12-month primary patency was 90.2%.

Patients remain in follow-up through 36 months, noted The VEINS press release.

The Duo venous system is an investigational device limited by federal United States law to investigational use. The Duo system was developed by Vesper Medical, Inc., which was acquired by Philips in a transaction announced in December 2021.