BTG wins FDA 510(k) for radiopaque beads, touts PneumRx coil study

BTG said today it won FDA 510(k) clearance for its LC Bead Lumi radiopaque embolic beads designed for embolization of hypervascular tumors and arteriovenous malformations and touted results from the Renew study of its PneumRx endobronchial coil implant. The Lumi was designed with radiopacity tech that allows for  real-time tracking of bead location during embolization procedures, London-based BTG said. “Embolization procedures using precisely calibrated microspheres such as LC Bead have delivered real benefits for patients, but to date we’ve only been able to measure the accuracy of the treatment delivery based on response to the procedure. With this technological breakthrough, for the 1st time I can see where the beads are as I’m conducting the embolization procedure. This has the potential to offer a new level of precision and control, and to allow me to make real-time adjustments to optimize how I treat the patient. I can see where it is going, and I can demonstrate to my patients that treatment has been placed exactly where it’s needed,” NIH Center for Interventional Oncology director Dr. Bradford Wood said in a press release. Clearance was based upon clinical safety and efficacy reports from 30 peer-reviewed clinical publications, the company said. “LC Bead Lumi reinforces BTG’s leadership in embolization technology and we look forward to clearances for additional radiopaque bead products worldwide. We are excited about th...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Oncology 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Clinical Trials BTG Source Type: news