An event far rarer than a total solar eclipse is approaching: the convening of the FDA’s medical device dispute resolution panel. This committee is designed to let the FDA know whether it has made a mistake in denying approval to a medical device on scientific grounds and, according to the FDA’s website, it has only met three times since its establishment in 1997.
The fourth meeting, scheduled for June 10, will see the panel evaluate the Oxiplex adhesion barrier gel developed by FzioMed for use in spinal surgeries. The omens are good: the only product to have received a positive verdict from the panel was a very similar surgical gel. That, however, was 13 years ago.
The first meeting of the dispute resolution panel, and the only positive one, occurred in September 2001 and concerned Lifecore Biomedical’s Intergel. Intergel is, like Oxiplex, designed to prevent surgical adhesions – scar tissue that connects tissues that should be separate. Both gels are applied towards the end of the operation to provide a barrier between tissues.
The panel voted 4 to 0 to recommend that the FDA approve the PMA for Intergel. The agency took the advice; approval followed two months later.
The other two occasions on which the dispute resolution panel met resulted in negative opinions. In December 2006 the panel voted 3-1 that Acorn Cardiovascular’s CorCap heart pump remain unapproved, and in April 2007 Cardima’s Revelation Tx catheter got a 5-nil vote against overturning the original not-approvable decision. The FDA followed the recommendations in both cases.
The June meeting for FzioMed – the name is pronounced "physiomed" – will see the seven-strong panel assess data from its pivotal US study, which formed part of the initial approval application and was scrutinised by the FDA’s orthopaedic and rehabilitation devices panel back in July 2008.
This study enrolled 352 patients who underwent lumbar disc surgery. FzioMed said it showed that patients in whom Oxiplex had been used had reduced postoperative leg and back pain compared with those who had undergone surgery without an adhesion barrier. According to the FDA, however, which conducted a different analysis, this pain reduction was not statistically significant.
“There was confusion because FDA presented a univariate analysis of the data and we presented a multivariate analysis – so basically, they confused the panel,” John Krelle, FzioMed’s chief executive, told EP Vantage. “This time the analysis of record is the multivariate analysis.”
As well as insisting on its own version of the pivotal trial data, FzioMed will present new data from studies conducted in Italy and China. In total, data from four trials will be presented, Mr Krelle says. “And another thing that’s different from 2008 is that all the studies we are putting forward for presentation have been published in peer-reviewed journals, so that makes a big difference.”
There is another possibility: that the panel will not meet after all. On at least three occasions a planned meeting has been called off, with the companies concerned going through other routes to get their devices reconsidered by the FDA.
Most recently a panel to assess Wright Medical’s Augment bone filler, scheduled for May 19 this year, was cancelled in March. Augment was rejected for a second time in 2013 (FDA rejection of Augment graft improves future for smaller companies, August 12, 2013).
Last month Wright brokered an agreement with the FDA under which it will submit a further amendment to the PMA application for Augment, including analyses of pre-existing before-and-after radiographs of study patients. The agency has said it will decide whether the PMA is approvable within 180 days of submission of the new data, itself expected any day.
If the answer is no – and Robert Palmisano, Wright’s chief exec, said “the parties’ positions are still far apart” – Wright intends to try the dispute resolution panel all over again.
FzioMed’s Mr Krelle is certainly aware that this might happen to his company. “We’re always open to mediation – if someone wants us to sit at a table and hash out some kind of a plan we’re happy to listen, and you never know with these things. But in the meantime we’re preparing to go full bore into the panel meeting in June. We think our data are very compelling.”
With just three meetings to extrapolate from it would be unwise to try to predict which way the panel will jump. Oxiplex has been on sale in Europe since 2002 and has been used in 350,000 operations, FzioMed says – but as has been seen time and again, the FDA is a much tougher gatekeeper than European regulators. There is every chance that it will remain unmoved.