US-based medical device company Fibralign has started enrolling for its investigator-led clinical study of surgical device, BioBridge Collagen Matrix, for the treatment of breast cancer-related lymphedema.
BioBridge is a sterile implantable biocompatible and biodegradable surgical mesh which is used during surgery to reinforce and repair weak and degraded soft tissue.
The device is composed of highly purified collagen and is based on the company's patented Nanoweave technology.
The study intends to test the efficacy of BioBridge Collagen Matrix in assisting and guiding lymphatic repair in patients with acquired lymphedema of upper and lower extremities.
Conducted in collaboration with the Stanford University, the study will enroll 36 patients and will use BioBridge Collagen Matrix as an adjunctive interventional device for vascularised lymph node transfer (VLNT) surgery.
VLNT is a widely practiced micro-surgical procedure for lymphedema which autologously transplants a lymph node as a tissue flap to the treatment area.
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Study lead investigator 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.”
A recently done preclinical study by Stanford University displayed BioBridge promoting the formation of new lymphatic vessels (lymphangiogenesis) by supporting endothelial cell attachment, alignment and migration, which are considered important for new lymphatic vessel formation.
Fibralign is also slated to report preliminary results of a separate ongoing pilot clinical study of BioBridge to support surgical procedure for breast cancer related lymphedema.