BD (Becton Dickinson) won FDA approval for its Venovo venous stent, which is the first stent available for treating iliofemoral venous occlusive disease.
Typically, arteries are the vessels that become narrow or even blocked from calcified plaque, but veins can also suffer from similar issues. The iliac and femoral veins near the groin are particularly prone to being occluded and that’s where the Venovo stent should help.
The Venovo is made of nitinol and it’s made to be very flexible, so as to be able to reach the target treatment zone. It sports high radial strength, resists compression, and a variety of available sizes should make it applicable for a wide range of legions within target veins. Most wide vessels and long lesions within the iliac and femoral veins should be treatable with the new stent.
“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” in a published statement said Dr. Michael Dake, University of Arizona and the principal investigator for the Venovo IDE trial. “Most importantly, it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing.”
Here are some details about the study that led to this approval, according to BD:
One-year results from the prospective, multicenter single-arm VERNACULAR trial involving 170 subjects demonstrated the safety and effectiveness of the Venovo™ venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction. The clinical findings showed a weighted primary patency rate of 88.3 percent, with a 96.9 percent patency rate in non-thrombotic lesions and an 81.3 percent patency rate in post-thrombotic lesions at 12 months, exceeding the performance goal of 74 percent. In addition, patients treated with the Venovo™ venous stent reported a statistically significant reduction in pain symptoms and improvement in quality of life (assessed by CIVIQ-20) at 12 months from baseline. The Venovo™ venous stent was also deployed successfully to the target lesion and showed adequate coverage in all cases, and there were no fractures seen at 12 months.