{"id":18852,"date":"2024-07-11T10:35:07","date_gmt":"2024-07-11T10:35:07","guid":{"rendered":"https:\/\/interhospi.com\/?p=18852"},"modified":"2024-07-11T10:35:07","modified_gmt":"2024-07-11T10:35:07","slug":"philips-duo-venous-stent-system-receives-fda-approval-and-completes-first-implant","status":"publish","type":"post","link":"https:\/\/interhospi.com\/philips-duo-venous-stent-system-receives-fda-approval-and-completes-first-implant\/","title":{"rendered":"Philips\u2019 Duo Venous Stent System receives FDA approval and completes first implant"},"content":{"rendered":"
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Philips\u2019 Duo Venous Stent System receives FDA approval and completes first implant<\/h1>chronic venous insufficiency<\/a><\/span>, Duo Venous Stent System<\/a><\/span>, Philips<\/a><\/span>, stent<\/a><\/span>, VIVID study<\/a><\/span>, Cardiology<\/a>, Product News<\/a> <\/span><\/span><\/header>\n<\/div><\/section>
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Royal Philips has announced the successful first implantation of its Duo Venous Stent System following premarket approval from the U.S. Food and Drug Administration. The device is indicated for treating symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI).<\/strong><\/p>\n

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\"Philips\u2019<\/h3>\n

First implantation marks milestone in CVI treatment<\/strong><\/h3>\n

On 11 June, Dr Erin Murphy, vascular surgeon and director of the Venous and Lymphatic Program at the Sanger Heart & Vascular Institute, Atrium Health, in Charlotte, N.C., performed the first implantation of Philips\u2019 Duo Venous Stent System outside of a clinical trial. Dr Murphy was an investigator in the VIVID study, which contributed to the device\u2019s FDA approval.<\/p>\n

Deep venous disease, affecting 25 million people globally, stems from venous thromboembolism \u2013 the third most common cardiovascular disease. The complexities of deep venous anatomy and obstructions present significant mechanical challenges for treatment.<\/p>\n

\"Philips\u2019<\/p>\n

Innovative design addresses venous anatomy challenges<\/strong><\/h3>\n

The Duo Venous Stent System comprises two stents \u2013 Duo Hybrid and Duo Extend \u2013 available in various sizes. The Duo Hybrid features an integrated design with multiple zones of differing mechanical properties within a single stent. For longer lesions, the Duo Extend can be smoothly overlapped with the Duo Hybrid to extend therapy.<\/p>\n

Dr Kush Desai, an interventional radiologist and associate professor at Northwestern University in Chicago, who was a leading enroller and investigator for the VIVID study, commented on the device\u2019s unique design: \u201cDuo is the first stent that offers a differential design for the challenges of venous anatomy \u2013 a focal area that withstands the forces of compression as well as the flexibility to accommodate curvature of the vessel.\u201d<\/p>\n

This design aims to minimise the risk of stent fracture and corrosion while providing an option for stenting within caudal veins with smaller diameters.<\/p>\n

VIVID study demonstrates safety and efficacy<\/strong><\/h3>\n

The VIVID study, a global, prospective, multi-centre, single-arm, non-blinded clinical trial, evaluated the safety and efficacy of the Philips Duo Venous Stent System in treating nonmalignant iliofemoral occlusive disease. The study enrolled 162 subjects at 30 centres, including patients with non-thrombotic iliac vein lesion (NIVL), post-thrombotic syndrome (PTS), and acute deep vein thrombosis (aDVT).<\/p>\n

The study met all primary safety and efficacy performance goals:<\/p>\n