Stanford University has begun enrollment in its investigator-led clinical study to assess the efficacy of a new surgical device for treating secondary lymphedema.
The trial will determine the effectiveness of Fibralign’s BioBridge Collagen Matrix in supporting and guiding lymphatic repair in patients with acquired lymphedema of upper and lower extremities.
BioBridge is a sterile implantable biocompatible and biodegradable surgical mesh, which received 510(k) clearance from the US Food and Drug Administration (FDA) for use in surgery to reinforce and repair soft tissue where weakness and deficiencies exist.
The device has not yet received approval for the treatment of lymphedema.
Featuring purified collagen, the novel device has been created by using the firm’s patented Nanoweave technology.
Stanford intends to recruit up to 36 patients in the trial, which will use BioBridge as an adjunctive interventional device for vascularized lymph node transfer (VLNT) surgery.
VLNT is a micro-surgical procedure for patients with lymphedema, in which an auxiliary lymph node is autologously transplanted as a tissue flap to the treatment area.
Stanford University cardiovascular medicine professor and the study’s lead investigator Dr Stanley Rockson said: “Based on results from our published successful large animal study, the research suggests that BioBridge has the potential to facilitate a truly successful surgical intervention that may restore lymphatic function, reduce swelling, and dramatically improve the patient’s quality of life.”