BlueLeaf Endovenous Valve Formation
InterVene has developed the first-ever endovascular device that doesn’t require an implant to address deep vein reflux. The device is intended to form new vein valves out of the layers of tissue that naturally make up a patient’s vein wall.
InterVene's BlueLeaf® Endovenous Valve Formation System is based on an open-surgical predicate (the Maleti Neovalve1), in which “autogenous” valves are also derived from the patient’s own vein wall. Intervene’s percutaneous approach avoids the trauma of open surgery, allows for multiple valves to be formed in a single procedure, and automates certain aspects of the technically-difficult open surgical procedure. The goal of this technology is to enable a larger number of doctors to treat their DVR patients who are in desperate need of a better solution.
Lugli, M.; Guerzoni, S.; Garofalo, M.; Smedile, G.; Maleti, O. "Neovalve Construction in Deep Venous Incompetence" J Vasc Surg 2009; 49:156-162
The BlueLeaf Procedure
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use. To be used exclusively for clinical research
Benchtop demonstration of valve mobility following Endovenous Valve Formation (EVF) with the BlueLeaf System in a cadaveric vein.
Left: Intravascular ultrasound view; Right: Angioscopic view.