Ethicon Endo-Surgery’s Sedasys system, which the agency declined to green-light in 2010, will go before an agency panel in December to plead for approval one more time.
The Johnson & Johnson (NYSE:JNJ) subsidiary is slated to appear before the FDA’s Medical Devices Dispute Resolution Panel to consider the FDA’s denial of the device on grounds that EES failed to prove Sedasys is safe enough for the U.S. market.
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.
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But 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.
"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 maintains 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; last March FDA chief Dr. Margaret Hamburg OK’d the dispute panel hearing.
The nine-member panel will review submissions from both sides before sending a report to the FDA’s chief scientist, Dr. Jesse Goodman, recommending whether to let the denial stand. Both sides will have a chance to respond before the final verdict is rendered.
Torax Linx lands FDA date
Torax’s Linx reflux management system is slated for a date with an FDA advisory panel as part of the review of its PMA.
The FDA’s gastroenterology & urology devices panel is set to convene Jan. 11, 2012, for a vote on whether to recommend approval for the Linx system, an implantable device designed to treat patients with gastroesophageal reflux disease.
Torax, which drummed up $4 million in June funding round, won CE Mark approval for the Linx GERD device in April and CE Mark approval for its Fenix continence restoration system just last week.
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