Restricted use for spinal tumour treatment:
This article was originally published in Clinica
Executive Summary
Interpore Cross International has received permission from the US FDA to sell a limited number of its expandable titanium spacers for replacing spinal segments under a humanitarian device exemption (HDE). The Telescopic Plate Spacer can be used where patients have had one of two spine vertebral bodies removed due to cancer. The Irvine, California-based company said the device is designed to allow insertion of bone graft material, adding that there are no other FDA-cleared devices that function in the same way. An HDE allows companies to market products for treating conditions that affect fewer than 4,000 people.