The success rate for patients that had the Dynesys implanted was 52% as compared to 40% for those patients that had the Silhouette implanted. The data indicated that Dynesys alleviated leg pain in 87% of the patients compared to 73% that had the Silhouette implanted. Even with this good news, there were some questions raised about potential bias in the evaluation saying a majority of the patients in the study were treated by researchers with a financial interest in the company.
The FDA released documents on Monday which stated that there might be bias from compensation when payments or stock holdings were analyzed for any influence in the proposed new use of the product. Currently, the product is marketed as an adjunct to fusion. One analysis by the FDA found a positive correlation between payments made to doctors and success rates for the device. Zimmer had no comment on the financial compensation issue. In the spirit of the World Series, Dynesys is rounding third and heading home! TSB wants to know what our readers think?