BlueLeaf endovenous valve formation system is claimed to be the first catheter-based solution for deep vein reflux (DVR), the failure of venous valves in the legs, which does not need an implant.
BlueLeaf system has been designed for the correction of one of the underlying causes of chronic venous insufficiency (CVI) by creating new vein valves out of a patient’s own vein wall tissue.
InterVene has secured the funding in a round led by new investor 3×5 Partners and participated by prior investors such as RiverVest Venture Partners, Boston Scientific and Correlation Ventures.
According to the company, around 6.5m Americans suffer from DVR and moderate to severe CVI, a disease characterised by elevated pressures in the leg veins.
InterVene CEO Fletcher Wilson said: “We expect to further demonstrate safety and clinical effectiveness while we optimize the BlueLeaf System and procedure in preparation for a subsequent pivotal study.”
The company will use the funds to expand its clinical research programme abroad, in addition to initiating trials for the system in the US through an investigational device exemption study.
DVR will lead to poor blood flow back to the heart and the pooling of blood in the legs, and the patients with this condition tend to progress to the most severe symptoms such as skin breakdown and chronic ulcers.
BlueLeaf system is a catheter-based approach, which will help physician to form new valves from the inner layer of the vein wall. The resulting autogenous valves will help decrease retrograde blood flow and reduce the symptoms associated with elevated venous pressures.
The BlueLeaf technique is said to be predicated on the Maleti Neovalve open-surgical procedure and helps patients to avoid the trauma of open surgery, enabling to form multiple valves in a single procedure and mechanise certain aspects of the technically-difficult open surgical procedure
NYU Langone Health surgery assistant professor and vascular surgeon Dr Mikel Sadek said: “This innovative technology may offer an alternative for patients needing procedural intervention to treat their disease.”
