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December 20, 2021
Vesper Duo Venous Stent System’s VIVID Pivotal Study Completes Enrollment
December 20, 2021—Vesper Medical, Inc., a developer of medical devices for deep venous disease, announced the completion of enrollment in the pivotal VIVID clinical trial of the Vesper Duo venous stent system for the treatment of patients with iliofemoral occlusive disease.
According to the company, the VIVID trial is a global prospective, multicenter, single-arm study to evaluate the safety and efficacy of the Vesper Duo stent system in the iliofemoral vein.
The global study enrolled 160 patients at centers in the United States and Europe. It will assess freedom from major adverse events at 30 days postprocedure and primary efficacy of the stented segment at 12 months. Patients enrolled in the study will be followed for 3 years.
Mahmood Razavi, MD, who is Director of Clinical Trials at St. Joseph Heart and Vascular Center in Orange, California, serves as Principal Study Investigator.
“I would like to thank all of the investigators and their teams for the commitment, skill, and hard work they brought to the VIVID trial,” commented Dr. Razavi in the company’s press release. “This has been a tremendous team effort that will ultimately benefit the millions of patients who suffer today with chronic venous insufficiency.”
On December 14, Royal Philips announced that it has signed an agreement to acquire Vesper Medical. The transaction, which is subject to customary closing conditions, is expected to be completed in the first quarter of 2022.
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