InterVene has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its BlueLeaf endovenous valve formation (EVF) system.

The company has developed the BlueLeaf system for the correction of one of the underlying causes of chronic venous insufficiency (CVI), deep vein reflux (DVR).

To do the correction, the system creates autologous vein valves out of the patient’s vein wall tissue through an endovascular, ultrasound image-guided approach.

BlueLeaf is said to be the first catheter-based solution developed for DVI, a condition that results due to the failure of venous valves in the legs. It will help to avoid the use of an implant.

The system is currently under clinical research in three separate study programmes across the world, including an early feasibility study (EFS) in the US.

Using the BlueLeaf system, the US and international investigators have formed new vein valves in more than 25 patients with varied anatomy, disease severity and etiology.

Both monocuspids and bicuspid valves were created by the investigators.

InterVene CEO Jeff Elkins said: “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.”

According to the company, around 6.5m Americans suffer from DVR and moderate to severe CVI, a disease indicated by increased pressure in the leg veins.

In June 2019, InterVene secured a $15m series B funding for first catheter-based system to correct deep vein valve failure.