Dutch health technology company Royal Philips has rolled out the Duo Venous Stent System, which received the US Food and Drug Association (FDA) premarket approval (PMA).
The Duo Venous Stent System is an implantable medical device indicated for treating symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI).
It was developed by Vesper Medical, a fully owned subsidiary of Philips, and marketed under the Philips brand.
The system comprises two stents, Duo Hybrid and Duo Extend, of different sizes.
Duo Hybrid combines multiple zones of differing mechanical properties into a single stent, while Duo Extend smoothly overlaps with the Duo Hybrid to extend therapy for long lesions.
The two stents are designed to work together and reduce the risk of stent fracture and corrosion and provide an option to stent within caudal veins with smaller diameters.
Philips vice president and peripheral vascular business leader Heather Hudnut Page said: “The launch of the Duo Venous Stent System represents another step forward in achieving our aspiration to innovate interventional procedures with advanced medical technology.
“In this context, we look forward to bringing the combined offering of intravascular ultrasound and Duo to the interdisciplinary teams – from vascular surgeons to interventional radiologists and interventional cardiologists – who share our overarching goal of enhancing patient care.”
Deep venous disease is caused due to venous thromboembolism, a condition that occurs when a blood clot forms in the vein and is the third most common cardiovascular disease.
Philips said that the Duo Venous Stent System is engineered to address the unique demands of venous anatomy and obstructions.
Recently, Sanger Heart & Vascular Institute venous and lymphatic program director and VIVID study investigator Erin Murphy used the system for the first time outside a clinical trial.
VIVID is a global, multi-centre, single-arm, non-blinded clinical trial conducted in the US and Poland, evaluating the safety and efficacy of the Philips Duo Venous Stent System.
The study enrolled 162 subjects either with non-thrombotic iliac vein lesions (NIVL), post-thrombotic syndrome (PTS) or acute deep vein thrombosis (aDVT), at 30 trial centres.
The VIVID study met all primary safety and efficacy performance goals, said the medical technology company.
St. Joseph Vascular interventional radiologist and principal investigator Mahmood Razavi said: “The VIVID study’s 12-month results demonstrate the safety and efficacy of the Duo Venous Stent System in the treatment of chronic venous insufficiency, 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 intravascular ultrasound, or IVUS. Ultimately, the new device promises to enable excellent clinical outcomes and drive significant quality of life improvements.”
VIVID study enroller and investigator Kush Desai said: “Duo is the first stent that offers a differential design for the challenges of venous anatomy – a focal area that withstands the forces of compression as well as the flexibility to accommodate curvature of the vessel.
“Consequently, Philips is well positioned to support CVI treatment by offering a robust portfolio of medical technology that includes both intravascular ultrasound and a differentiated venous stenting system.”
