FDA News

FDA approves stent system for iliofemoral venous obstructive disease

Mahmood K. Razavi
Mahmood K. Razavi

Boston Scientific announced that a stent system for the treatment of patients with iliofemoral venous obstructive disease has been approved by the FDA.

The venous stent system (Vici) is strong and crush resistant, allowing it to restore blood flow through the creation of a cylindrical patent vessel, according to a press release from the company.

“For those suffering from venous obstructive disease, their quality of life may suffer without treatment options optimized for the disease,” Mahmood K. Razavi, MD, FSIR, FSVM, director of the department of clinical trials at the Heart & Vascular Center of St. Joseph Hospital in Orange, California, said in the release. “With the approval of the Vici stent, clinicians now have access to a stent that was purposely developed and engineered to resist the vessel compression and anatomical tortuosity commonly found within the iliofemoral venous system, enabling our ability to deliver best outcomes for our patients.”

The FDA approval was based on results from the VIRTUS study, according to the release. As Cardiology Today’s Intervention previously reported, this venous stent was associate with high rates of primary patency and low rates of adverse events at 12 months.

Disclosures: The VIRTUS study was funded by Veniti, now part of Boston Scientific. Razavi reports he served as lead investigator on the trial supported by Boston Scientific.

Mahmood K. Razavi
Mahmood K. Razavi

Boston Scientific announced that a stent system for the treatment of patients with iliofemoral venous obstructive disease has been approved by the FDA.

The venous stent system (Vici) is strong and crush resistant, allowing it to restore blood flow through the creation of a cylindrical patent vessel, according to a press release from the company.

“For those suffering from venous obstructive disease, their quality of life may suffer without treatment options optimized for the disease,” Mahmood K. Razavi, MD, FSIR, FSVM, director of the department of clinical trials at the Heart & Vascular Center of St. Joseph Hospital in Orange, California, said in the release. “With the approval of the Vici stent, clinicians now have access to a stent that was purposely developed and engineered to resist the vessel compression and anatomical tortuosity commonly found within the iliofemoral venous system, enabling our ability to deliver best outcomes for our patients.”

The FDA approval was based on results from the VIRTUS study, according to the release. As Cardiology Today’s Intervention previously reported, this venous stent was associate with high rates of primary patency and low rates of adverse events at 12 months.

Disclosures: The VIRTUS study was funded by Veniti, now part of Boston Scientific. Razavi reports he served as lead investigator on the trial supported by Boston Scientific.