FzioMed Inc. Files Citizen Petition for Reconsideration Following FDA Rejection of Its Spinal Gel PMA
Published: Dec 07, 2012
“Patients and spine surgeons across the United States are eager to take advantage of the safe, pain-relieving benefits of Oxiplex and hope the FDA will reconsider its decision to deny access to U.S. patients”
There have not been any reports of safety issues associated with the device among more than 300,000 surgical patients who have been treated with Oxiplex. Those safe, successful surgical procedures occurred in countries whose regulatory agencies are science-based and equally as stringent as the U.S. FDA.
“Patients and spine surgeons across the United States are eager to take advantage of the safe, pain-relieving benefits of Oxiplex and hope the FDA will reconsider its decision to deny access to U.S. patients,” said John Krelle, President and CEO of FzioMed, which recently celebrated 16 years in business. “FzioMed strongly believes that there are several significant issues of scientific dispute that warrant review by an independent advisory committee.”
Mr. Krelle went on to say that should the FDA reverse its decision, the company would be in a position to add several hundred well-paying jobs to its U.S. operations. When the FDA first issued a Not Approvable letter in September of 2008, FzioMed was forced to downsize its California operations by 50 percent and to outsource jobs overseas.
FzioMed is a privately held medical device company founded in 1996. The company develops, manufactures and commercializes absorbable surgical biomaterials based on its patented polymer science. FzioMed adhesion barriers are used in many surgical applications including spine, orthopedics, hand, tendon, peripheral nerve, gynecology and general surgery. Its spine gel is the #1 adhesion barrier gel for spine surgery worldwide and is distributed by Medtronic, DePuy and other independent distributors. For more information, please visit www.fziomed.com
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.
John Krelle, President & CEO