CryoLife to expand BioGlue trials in US:
This article was originally published in Clinica
CryoLife intends to apply to the US FDA early next year to extend the investigational device exemption (IDE) for its BioGlue surgical adhesive to include its use in pulmonary sealing and repair, an indication for which the product is marketed in Europe. At a meeting of the Western Thoracic Surgical Association in Hawaii last month, the Atlanta, Georgia-based company said a preliminary animal study was reported of the bronchoscopic application of BioGlue as an alternative to standard lung volume reduction (LVR). LVR, which involves removing a portion of diseased lung, is used to improve respiratory function and quality of life in patients with end-stage emphysema.