BAMF Spine approval delayed; US launch slated for next year
This article was originally published in Clinica
The BAMF (balloon-assisted management of spine fractures) Spine product, developed by AOI Medical to treat compression fractures of the spine caused by osteoporosis, cancer or trauma, may not reach market until the end of next year. The US FDA has extended the consultation period for the device's 510(k) submission for a further 90 days, to consider the necessity of a confirmatory study. Orlando, Florida-based AOI expects to meet with the FDA again in late October, but acknowledges that US launch of BAMF Spine will occur either in the first quarter of 2008 if no clinical trials are required, or the second half of 2008 if trials are required.