Philips launches Duo venous stent system with FDA approval

Philips(NYSE: PHG)+ today announced the first implant of its Duo venous stent system following FDA premarket […]

Philips(NYSE: PHG)+ today announced the first implant of its Duo venous stent system following FDA premarket approval.

Duo, an implantable medical device, treats symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI). Amsterdam-based Philips added Duo to its portfolio when it acquired Vesper Medical in 2021.

On June 11, Dr. Erin Murphy of the Sanger Heart & Vascular Institute, Atrium Health, in Charlotte, North Carolina, successfully used Duo for the first time outside a clinical trial. Murphy also served as an investigator in the VIVID study of the stent, which contributed to the device’s FDA approval.

Duo features two stents — the Duo Hybrid and Duo Extend — of various sizes, Philips said in a news release. It has a distinct, integrated design that combines multiple zones of differing mechanical properties into a single stent. For long lesions, Duo Extend smoothly overlaps with Duo Hybrid to extend therapy. The stents work together and minimize the risk of fracture and corrosion while catering to caudal veins with smaller diameters.

Philips’ VIVID study of 162 subjects met all of its primary safety and efficacy goals. Primary patency of 90.2 exceeded the effectiveness target of 77.3%. The safety endpoint of 98.7% came in well ahead of the goal of 89%. Philips also reported sustained improvements in quality of life as a result of the stent system.

“The launch of the Duo venous stent system represents another step forward in achieving our aspiration to innovate interventional procedures with advanced medical technology,” said Heather Hudnut Page, VP and business leader of Peripheral Vascular at Philips. “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.”

Original Article (https://www.massdevice.com/philips-launches-duo-venous-stent-system-with-fda-approval/)