CAUTION: Investigational Device. Limited by federal (United States) law to investigational use.
Additional evidence of device safety and efficacy is currently being collected under the controls of an investigational device exemption clinical study (VIVID) for use in support of a future PMA application with the FDA. www.clinicaltrials.gov/NCT04580160
Intended Use:
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The Vesper DUO Venous Stent System is intended for use in the iliac and common femoral veins for improving luminal diameter in symptomatic venous outflow obstructions
Contraindications for Use:
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Patients with a known hypersensitivity to nickel-titanium alloy (Nitinol)
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Patients unable to receive standard medication used for interventional procedures including anticoagulants, contrast agents and antiplatelet therapy
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Patients who are judged to have a lesion that prevents complete inflation of a balloon dilation catheter or proper placement of the stent or the stent delivery system
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Tortuous vascular anatomy significant enough to prevent safe introduction and passage of the device
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The Vesper DUO stent is not designed for use in procedures that require jugular or contralateral access and therefore is absolutely contraindicated from these access sites
Device is not approved for sale in the United States.