The BioBridge collagen matrix is an implantable, biocompatible and biodegradable surgical mesh with 510(k) clearance for use in surgery to “reinforce and repair soft tissue where weakness and deficiencies exist,” the company said, and its not currently cleared for treating lymphedema.
The trial aims to evaluate the effectiveness of the BioBridge in supporting and guiding lymphatic repair in patients with acquired lymphedema of the upper and lower extremities.
“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,” study lead investigator Dr. Stanley Rockson of the Stanford Center for Lymphatic and Venous Disorders said in a press release.
Stanford is slated to enroll 36 patients in the study, which will use the BioBridge as an adjunctive interventional device for vascularized lymph node transfer surgery.
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