Royal Philips, the parent company of Philips, announced the first U.S. patient was successfully treated using an intravascular ultrasound (IVUS) system and two new types of flexible stents.
The technology, called Duo Venous Stent, addresses chronic venous insufficiency (CVI) and symptomatic venous outflow obstruction, according to Philips.
It consists of two stents, Duo Hybrid and Duo Extend, of various sizes. Duo Hybrid has a distinct integrated design that combines multiple zones of differing mechanical properties into a single stent. For long lesions, Duo Extend overlaps with the Duo Hybrid to extend therapy. The two stents are designed to work together and minimize the risk of stent fracture and corrosion, while providing an option to stent within caudal veins with smaller diameters, Philips said.
One of two types of stents in the Duo Venous Stent System from Vesper Medical and Philips.Philips
Sanger Heart and Vascular Institute, Atrium Health, in Charlotte, NC, performed the procedure that marks the medical device's launch since U.S. Food and Drug Administration premarket approval in December. Vesper Medical, a wholly-owned subsidiary of Philips, developed the system.
In the announcement, Philips referenced the VIVID study, a global, prospective, multicenter, single-arm, nonblinded clinical trial conducted in the U.S. and Poland. VIVID evaluated the safety and efficacy of the Philips Duo Venous Stent System in the treatment of nonmalignant iliofemoral occlusive disease. Philips noted that the VIVID study was the first clinical trial to mandate IVUS use to aid in lesion assessment and stent sizing prior to device implantation.
