InterVene’s BlueLeaf Endovenous Valve Formation System Granted FDA Breakthrough Device Designation

December 13, 2021—InterVene Inc. announced that it has received Breakthrough Device designation from the FDA for the company’s BlueLeaf endovenous valve formation (EVF) system. The BlueLeaf system is a catheter-based solution to treat deep vein reflux that does not require an implant.

According to Intervene, the BlueLeaf system is designed to correct deep vein reflux—one of the underlying causes of chronic venous insufficiency—by forming new, autologous vein valves out of the patient’s vein wall tissue via an endovascular, ultrasound image-guided approach.

Clinical research of the BlueLeaf system is underway in three study programs worldwide, including an early feasibility study in the United States (INFINITE-US).

To date, more than 25 patients with varied anatomy, disease severity, and etiology have had new vein valves formed using the BlueLeaf system in procedures conducted by investigators in the United States and other countries. Both monocuspids and bicuspid valves have been formed, advised Intervene.

The company noted that the FDA’s 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 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 nonimplant valve technology as treatment for the severe symptoms they frequently experience,” commented William Marston, MD, in Intervene’s press release. “Solutions to deep vein reflux 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.”

Dr. Marston is the George Johnson Jr. Distinguished Professor of Vascular Surgery at the University of North Carolina School of Medicine in Chapel Hill, North Carolina.