InterVene’s BlueLeaf Endovenous Valve Formation (EVF) System Granted Breakthrough Device Designation by the FDA

InterVene’s BlueLeaf Endovenous Valve Formation (EVF) System Granted Breakthrough Device Designation by the FDA

Below, we are re-publishing with permission the press-release issued by InterVene, Inc. on December 13, 2021

December 13, 2021 07:00 AM Eastern Standard Time

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–InterVene Inc. announced today that it has received Breakthrough Device Designation by the FDA for the company’s BlueLeaf® Endovenous Valve Formation System. BlueLeaf is the first catheter-based solution developed for deep vein reflux — the failure of venous valves in the legs — which does not require an implant. Clinical research is underway in three separate study programs worldwide, including an Early Feasibility Study (EFS) in the US.

The Breakthrough Device Designation is granted when a device meets several criteria, including providing more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

The BlueLeaf System is designed to correct one of the underlying causes of chronic venous insufficiency (CVI), Deep Vein Reflux (DVR), by forming new, autologous vein valves out of the patient’s vein wall tissue via an endovascular, ultrasound image-guided approach. To date, over 25 patients with varied anatomy, disease severity, and etiology have had new vein valves formed by US and international investigators using the BlueLeaf System. Both monocuspids and bicuspid valves have been formed.

“This is a meaningful milestone for the company which offers the potential for a more timely clinical research and regulatory process for BlueLeaf. Given the debilitating nature of DVR and the lack of an effective treatment option for these patients, we’re pleased with the FDA’s decision and look forward to productive collaboration with the agency. In addition, potential economic and reimbursement benefits remain an ongoing process which we’ll follow closely as we plan and develop the next phase of our clinical research,” noted InterVene CEO Jeff Elkins.

Approximately 6.5M Americans suffer from DVR and moderate to severe CVI, a disease characterized by elevated pressure in the leg veins. DVR involves the failure of venous valves in the legs, notably in those whose valves are damaged by post-thrombotic syndrome (PTS) after iliofemoral deep vein thrombosis (DVT), leading to poor blood flow back to the heart and pooling of blood in the legs. DVR patients tend to progress to the most severe symptoms, including skin breakdown and chronic ulcers, negatively impacting their quality of lifeThe current standard of palliative treatment involves compression therapy, leg elevation and local wound care yet does not address the underlying problem of deep vein valve failure.

“The FDA’s Designation of the BlueLeaf EVF System as Breakthrough is an important recognition of both the tremendous unmet need for Deep Vein Reflux patients and the potential of the novel non-implant valve technology as treatment for the severe symptoms they frequently experience. Solutions to DVR have been elusive despite decades of research, and InterVene’s autologous, endovenous approach is worthy of prioritization, so the designation is a fitting and positive development,” said William Marston, M.D., the George Johnson Jr. Distinguished Professor of Vascular Surgery at the University of North Carolina School of Medicine.

About InterVene Inc.

Located in South San Francisco, InterVene is a product of the Stanford Biodesign Fellowship program and a former Company-In-Residence at the Fogarty Institute for Innovation. For more information and a video animation of the BlueLeaf procedure, visit

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