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An Implantable Bioprosthetic Venous Valve to Establish Deep Vein Competence for Post-Thrombotic Syndrome

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1 Credit CME

VenoValve is a bioprosthetic device designed to improve valvular competence in the deep venous system of the lower extremities and treat deep venous insufficiency (DVI). First-in-human studies have focused on use in patients with DVI stemming from post-thrombotic syndrome, although design features portend utility in those with primary disease as well. The innovation consists of a porcine aortic valve leaflet dissected and structured in a nonexpandable 10-mm stainless-steel frame forming a monocusp, unidirectional valve (Figure, A). The device is preserved with glutaraldehyde, which maintains the tissue's anatomic integrity, strength, and flexibility properties,1 packaged in normal saline and sterilized by gamma radiation. VenoValve is implanted in the femoral vein through a thigh incision and secured with monofilament sutures (Figure, B). Early studies have required a vein of at least 8-mm diameter and, in some cases, a limited focal endovenectomy or bovine pericardial patch to close the venotomy. Proximal venous obstruction should be ruled out or treated prior to use of the device, and Duplex should be used to ensure adequate unidirectional flow after implantation.

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Corresponding Author: Todd E. Rasmussen, MD, Department of Surgery, Mayo Clinic, Rochester, MN 55905 (rasmussen.todd@mayo.edu).

Published Online: January 18, 2023. doi:10.1001/jamasurg.2022.6362

Conflict of Interest Disclosures: Dr Cifuentes reported work as a research fellow with Dr Ulloa as principal investigator. Dr Ulloa reported grants from EnVVeno Medical Corporation and Hancock Jaffe Laboratories. No other disclosures were reported.

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