CE mark

Fibralign’s Surgical Mesh Receives CE Mark for Lymphedema

September 16, 2020

Fibralign has received CE mark certification for its BioBridge collagen matrix, a biodegradable surgical mesh for the treatment of lymphedema.

The sterile, biocompatible mesh is now cleared to support the surgical treatment of lymphedema, a condition in which the arm or leg swells due to a blockage in the lymphatic system.

The company said that preclinical studies have shown its collagen matrix helps in repairing damaged lymphatic vessels that cause the condition. The device has not yet received clearance from the FDA for lymphedema, though the agency has granted it a 510(k) clearance for reinforcing and repairing soft tissue.

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