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 the possibilities that our new product offers.  It’s a new standard of care which would have seemed like science fiction only a generation ago. What we achieve with LC Bead Lumi can only be done in partnership with interventional radiologists and multidisciplinary teams. With that, we will work passionately to communicate the power of our product to improve human health,” commercial development & interventional oncology marketing veep Ken Pugh said in a prepared statement.

The company said results from the Renew study of its PneumRx endobronchial coil implant for treating patients with homogenous and/or heterogenous severe emphysema met both primary and secondary endpoints for the trial.

The PneumRx endobronchial coil implant is a nitinol coil designed to be implanted in the sub-segmental airways of the lungs for patients with severe emphysema, BTG said.

The 315-patient randomized Renew trial reported a 10.2 meter benefit in a 6-minute walk test at 12 months compared to the control patient group. Results showed statistically significant improvements in quality of life as measured by the St. George Respiratory Questionnaire at 12 months and increased lung function as measured by the Forced Expiratory Volume, the company said.

“We are delighted with the successful outcome of Renew, showing significant benefit in patients treated with the PneumRx Coils in one of the largest randomized controlled clinical trials of a medical device in patients with severe emphysema to date incorporating both patient reported and objective outcomes. We will now progress our regulatory application in the US, which we anticipate submitting around mid-2016,” CEO Louise Makin said in prepared remarks.

The primary endpoint of the study was the 12-month mean absolute improvement from a baseline on the 6-minute walk test. The secondary endpoints included a responder analysis of the 6-minute walk test, FEV1 mean percent change measured using spirometry and SGRQ mean absolute difference.

BTG CEO Makin said the positive developments demonstrated the company was delivering on its strategy to become a world-leading specialist healthcare business.

Information from Reuters was used in this article.

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