Kyphon in Japan
This article was originally published in The Gray Sheet
Executive Summary
Kyphoplasty study is first of its kind under Japan's new good clinical practice guidelines. Firm anticipates enrolling 80 patients at six centers, with enrollment expected to finish in 2006. Follow-up could extend for two years and will be bolstered with existing U.S. and European data to support an application for kyphoplasty in Japan. Japanese patients suffer from 500,000 vertebral compression fractures each year, according to Kyphon...