FDA conditionally approves Interventional Spine’s PercuDyn system


Interventional Spine has announced that the FDA has approved the Company’s investigational device exemption (IDE) application for its PercuDyn System for the treatment of degenerative disc disease (DDD). This approval is conditional upon the Company providing some additional information to the FDA.

Walter Cuevas, CEO, commented, “In markets outside the US the PercuDyn System is chosen clinically by patients and their physicians when conservative care fails. The results we have seen so far show that patients treated with PercuDyn have less pain in a significantly shorter period of time with noticeably less trauma and complications as compared to open fusion surgery. As a result, patients treated with the PercuDyn System can resume normal activities within days, rather than months, almost immediately after the PERCUTANEOUS intervention. The PercuDyn System is usually implanted in an outpatient setting, eliminating the cost associated with pre- and post-operative hospital stays.