Bioring gets FDA filip for annuloplasty ring trial
This article was originally published in Clinica
The FDA has given a boost to Bioring's efforts to gain US marketing approval for its biodegradable annuloplasty ring by awarding the Swiss company a grant of an undisclosed sum for a clinical trial of the device. The trial will assess the efficacy and safety of the Kalangos ring in the treatment of atrioventricular valve regurgitation in paediatric patients. The ring, used for mitral and tricuspid valve repair, is a three-dimensional flexible device designed for quick and easy implantation via a minimally-invasive surgical procedure, according to Lonay-based Bioring. It restores normal organ function, while gradually degrading over a six-month period as the natural organ regrows. The Kalangos annuloplasty ring was CE marked in 2005, and is currently used in the US under a compassionate use exemption.