Back in September 2008, FDA denied FzioMed, Inc.’s premarket approval application for its product Oxiplex Gel—an absorbable, clear, viscoelastic gel that some surgeons apply during lumbar spine surgery immediately prior to wound closure. FzioMed has now filed a petition for reconsideration with the FDA under Section 515(g)(2)(a) of the Food Drug Cosmetic Act, Section 562 of the FD&C act and Part 10.33 of Title 21 Code of Federal regulations.
Company officials maintain that, based on four studies involving more than 500 patients and nearly 10 years of commercial use benefitting more than 300, 000 patients outside the U.S., Oxiplex has proven itself to be an effective surgical adjuvant that significantly reduces the effects of failed back surgery syndrome (FBSS) such as leg pain and neurological symptoms. They note that their product is available in nearly 70 countries, including those in the European Union, Australia, Canada, Brazil, Mexico and South Korea. According to information supplied by FzioMed, the United States is the only country to deny an application for approval of Oxiplex.
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, company president and CEO, in a December 3 press release. “FzioMed strongly believes that there are several significant issues of scientific dispute that warrant review by an independent advisory committee.
Krelle went on to say that 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. He added that those surgical procedures occurred in countries whose regulatory agencies are science-based and equally as stringent as the U.S. FDA.
FzioMed is a privately held medical device company, founded in 1996, that develops, manufactures and commercializes absorbable surgical biomaterials based on its patented polymer science. Company officials report that FzioMed adhesion barriers are used in many surgical applications including spine, orthopedics, hand, tendon, peripheral nerve, gynecology and general surgery. Its spine gel is distributed by Medtronic, Inc., DePuy and other independent distributors.
It’s a shame that a safe and effective like Oxiplex is not available for use in the U.S., after a longtime positive worldwide experience !
I had some members of my family treated in Italy and Switzerland years ago, with excellent outcome!