FzioMed, Inc. is going to get its day in the FDA’s “Court”—the Medical Device Dispute Resolution Panel (MDDRP)—on June 10, 2014.
Medical Device Dispute Resolution Panel
The MDDRP advises the Commissioner of the FDA on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, significant regulatory decisions and actions by the FDA, and Agency guidance and policies. The panel is convened infrequently and makes recommendations on issues that are lacking resolution, in this case it will decide whether to overturn the Center for Devices and Radiological Health (CDRH) denial of the Oxiplex PMA (premarket approval) or uphold the previous decision.
A Decade of Decisions
”For more than a decade, FzioMed has been seeking approval of Oxiplex in the U.S., ” said John Krelle, FzioMed’s president and CEO. “Over the course of its review, the FDA’s Center for Devices and Radiological Health (CDRH) has reviewed data on approximately 500 patients from four peer-reviewed published clinical studies spanning three continents. The totality of data from the various studies submitted to FDA on Oxiplex, combined with extensive clinical success achieved around the world, demonstrate that Oxiplex can offer increased clinical benefit compared to discectomy surgery alone, while presenting no significant safety risk.
FzioMed filed their PMA application in August 2007. The agency’s orthopedic panel met in July 2008 and voted to recommend against approval. The FDA then issued “not approval” letters in September 2008 and once again in January 2010. In October 2011, the company requested supervisory review by the Office of the Center Director of the not approvable decision. A letter issued on October 9, 2012, by William Maisel, M.D., on behalf of the Office of the Center Director, upheld the not approvable decision.
The company then chose to exercise the option to consider the October 9, 2012 decision letter to be a denial of approval of the PMA and requested an administrative review by filing a petition for reconsideration on November 5, 2012. On November 4, 2013, the company announced that FDA Commissioner Margaret Hamburg, M.D. approved their petition for an independent review of their PMA and a rare special Medical Devices Dispute Resolution Panel meeting.
Shades of Adcon-L
There are echoes of Gliatech’s Adcon-L’s FDA approval and subsequent recall due to concerns over possible contamination of material from the aluminized paper liner in this case. As of 2012, according to Millennium Research Group, there were no adhesion barriers approved for orthopedic application in the U.S.
Oxiplex
Oxiplex is an absorbable, clear, viscoelastic hydrogel that is applied during lumbar spine surgery. Oxiplex has been approved for sale in the European Union since 2002 and is now approved in 70 countries. It has been used in more than 350, 000 surgeries worldwide. The company has been working for 12 years to gain FDA approval to market this device in the U.S.
The company says Oxiplex has been investigated in two U.S studies under an FDA-approved Investigational Device Exemption (IDE), as well as studies in Italy and China, that confirm the results of the U.S. study in subjects undergoing discectomy surgery. “The IDE pivotal study, which required more than five years to complete, found that subjects having both predominant leg pain and severe preoperative back pain, experienced a greater reduction in leg and back pain when treated with Oxiplex compared to undergoing surgery alone, ” stated the company press release.
In addition, the company statement says patients receiving Oxiplex had fewer reoperations and more patients achieving zero pain scores at study end compared to those receiving discectomy surgery only. “This group of patients has been identified in the literature (including the widely referenced SPORT study as one that often does not experience the magnitude of benefit in reduction of leg pain that is generally experienced following discectomy surgery. Other studies including those from Kleinstueck et al. and el Barzouhi et al., also found higher levels of back pain to be a predictor of a poorer outcome after such surgery resulting in large groups of patients with unsatisfactory outcomes. This is the target group that benefits the most from the adjunctive effect of Oxiplex.”
