Sam Brusco, Associate Editor12.13.21
InterVene Inc. has received FDA Breakthrough Device Designation for its BluLeaf endovenous valve formation system. The catheter-based solution for deep vein reflux (DVR—venous vein failure in the legs) is the first of its kind to not require an implant, according to the company. Worldwide there are three clinical study programs taking place, including a U.S. early feasibility study.
The BlueLeaf system aims to correct deep vein reflux—an underlying cause of chronic venous insufficiency (CVI)—by creating new, autologous vein valves out of the patient’s vein wall tissue using an endovascular, ultrasound image-guided procedure. According to InterVene, globally more than 25 patients with varied anatomy, disease severity, and etiology had new vain valves formed using BlueLeaf. Both monocuspids and bicuspid valves were formed.
“This is a meaningful milestone for the company which offers the potential for a more timely clinical research and regulatory process for BlueLeaf,” InterVene CEO Jeff Elkins told the press. “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.”
About 6.5 million Americans suffer from DVR and moderate to severe CVI. The failure of venous valves in the legs, especially those damaged by post-thrombotic syndrome after iliofemoral deep vein thrombosis, leads to poor blood flow back to the heart and blood pooling in the legs. Those afflicted with DVR tend to progress to very severe symptoms like skin breakdown and chronic ulcers. Current standard palliative treatments include compression therapy, leg elevation, and local wound care.
However, this doesn’t address the underlying issue 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,” said William Marston, M.D., the George Johnson Jr. Distinguished Professor of Vascular Surgery at the University of North Carolina School of Medicine. “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.”
The BlueLeaf system aims to correct deep vein reflux—an underlying cause of chronic venous insufficiency (CVI)—by creating new, autologous vein valves out of the patient’s vein wall tissue using an endovascular, ultrasound image-guided procedure. According to InterVene, globally more than 25 patients with varied anatomy, disease severity, and etiology had new vain valves formed using BlueLeaf. Both monocuspids and bicuspid valves were formed.
“This is a meaningful milestone for the company which offers the potential for a more timely clinical research and regulatory process for BlueLeaf,” InterVene CEO Jeff Elkins told the press. “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.”
About 6.5 million Americans suffer from DVR and moderate to severe CVI. The failure of venous valves in the legs, especially those damaged by post-thrombotic syndrome after iliofemoral deep vein thrombosis, leads to poor blood flow back to the heart and blood pooling in the legs. Those afflicted with DVR tend to progress to very severe symptoms like skin breakdown and chronic ulcers. Current standard palliative treatments include compression therapy, leg elevation, and local wound care.
However, this doesn’t address the underlying issue 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,” said William Marston, M.D., the George Johnson Jr. Distinguished Professor of Vascular Surgery at the University of North Carolina School of Medicine. “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.”