FzioMed said today that a dispute resolution panel slated for next month for its Oxiplex spinal surgery gel has been postponed so the FDA can review more clinical data.
Once-scorned biomaterials maker FzioMed is getting another day with the FDA to discuss its Oxiplex spinal surgery gel, which was rejected by U.S. healthcare officials in 2008.
FzioMed will meet June 10, 2014, with the FDA’s Medical Device Dispute Resolution Panel to discuss the "approvability" of the Oxiplex gel, which has been on the European market since 2012 and is approved for sale in 70 countries. The product has already been used in more than 350,000 surgeries, FzioMed said.
FzioMed said the FDA granted an independent review of its pre-market approval application for the Oxiplex spinal surgery gel.
San Luis Obispo, Calif.-based FzioMed originally filed its PMA application for Oxiplex in October 2007. The FDA responded with a "not approvable letter" back in July 2008 after determining that FzioMed hadn’t provided sufficient evidence of the gel’s effectiveness in aiding in healing following lower back spinal surgery.
Privately held medical device maker FzioMed won Australian regulatory approval for its Dynavisc post-surgical gel, an absorbable gel applied to tendons and nerves to reduce adverse events after surgery.
California device maker FzioMed filed a citizen’s petition with the commissioner of the FDA, asking the agency to re-open a rejected premarket approval application for its Oxiplex spinal surgery gel.
FzioMed had originally filed its PMA for Oxiplex in October 2007, getting a "not approvable letter" back in July 2008 after the FDA determined that FzioMed hadn’t provided sufficient evidence of the gel’s effectiveness in aiding in healing following lower back spinal surgery.
Medtronic (NYSE:MDT) won 510(k) clearance from the FDA for the Aquamantys surgical sealer it acquired when it paid $480 million for Salient Surgical Technologies last year.