The firm’s stent system, called Vici, was designed to overcome the challenges of durability and ease of use physicians face when working with stents with the millions of patients affected by venous disease worldwide, according to a statement from Veniti.
The FDA Investigational Device Exemption study will include 200 patients and take place over the course of 60 months to ensure patient safety post-surgery.
Last year, Veniti raised more than $17 million from various life sciences venture capital firms to demonstrate patient benefit from its Vici stent system.
More articles on medical devices:
FDA investigates St. Jude Medical’s cardiac devices for potential security flaws
Medicaid rebates for Mylan’s EpiPen challenged by US lawmakers
Nestlé to acquire medical device company Phagenesis: 4 things to know