Johnson & Johnson’s (NYSE:JNJ) Ethicon Endo-Surgery division will get another round with the FDA after its original pre-market application for the Sedasys computer-assisted personalized sedation system was denied.
The agency has already re-opened the Cincinnati-based company’s PMA and agreed to "review it expeditiously," worldwide communications director David Shaffer told MassDevice. In turn, EES cancelled its request that a panel of experts review the original denial.
Although the expert review was slated for Dec. 14, Ethicon determined that re-opening the PMA would lead to approval faster than the planned meeting before the FDA’s Medical Devices Dispute Resolution Panel, Shaffer said.
The company filed its PMA application in March 2008. A little more than a year later, an FDA advisory panel voted 8-2 to recommend approval; although its panels’ votes are not binding, the agency often follows their lead. Still, in February 2010, the FDA denied the application, citing evidence that the Sedasys system "is associated with an increased incidence of deeper-than-intended sedation," according to the FDA.
EES appealed the decision and FDA commissioner Dr. Margaret Hamburg OK’d the review in March. The agency ordered the December meeting Nov. 21. A week later EES withdrew its request, according to the FDA.
"By letter dated November 28, 2011, EES notified OC that EES ‘withdraws its request for administrative review’ of that order," according to a notice in the Federal Register. "Because EES has withdrawn its petition for review of CDRH’s denial of approval of the Sedasys PMA, OC regards the matter it initiated closed and is, accordingly, canceling the previously mentioned meeting of the Medical Devices Dispute Resolution Panel scheduled for December 14, 2011."
"CDRH’s denial order maintained that the data provided demonstrates that ‘the Sedasys system is associated with an increased incidence of deeper-than-intended sedation, including episodes of general anesthesia, compared to the Current Standard of Care arm that was used as a control,’" according to the agency. "CDRH asserted in that order that it considered these observations to represent a ‘serious safety signal’ that would require restricting use of the device to persons trained in the administration of general anesthesia."
Ethicon E-S maintained that the five patients who experienced the episodes of general anesthesia are not a safety concern because "none experienced any apnea or oxygen desaturation," according to a federal meeting announcement. Moreover, the company says, Sedasys was designed with systems to avoid apnea and oxygen desaturation, features that helped it achieve "a significant reduction in the primary safety endpoint."
After the initial denial, EES asked the FDA to reconsider in light of the positive advisory panel vote in March 2010, but was shot down in October. In November the agency changed its mind, agreeing to allow the appeal to be heard.
The nine-member panel was to have reviewed submissions from both sides before sending a report to the FDA’s chief scientist, Dr. Jesse Goodman, recommending whether to let the denial stand.
The new agreement defines a path forward for reviewing Sedasys and includes next steps for the device’s labeling, post-approval studies and training for physicians who use the sedation device, Shaffer told us.