Sphincter specialist Torax Medical Inc. has taken a significant step towards FDA approval for its Linx device, designed for treatment of Gastro-Oesophageal-Reflux Disease(GORD…or GERD depending on which side of the pond you reside)by gaining the unanimous support of FDA’s 9 member advisory panel. The expert panel voted yes to all 3 questions, affirming the efficacy, safety, and favorable risk-benefit ratio for the novel treatment for GERD. FDA Panel support is important as a precursor to FDA approval.
Torax Medical Inc., based in St Paul, Minnesota, gained CE mark approval for the device in April 2010 and followed this up with CE mark approval for its Fenix system, based on the same design principle, but intended to address almost the other end of the Gastrointestinal (GI) tract, being targeted at faecal incontinence. Both devices work on the principle of supplementing bodily “sphincters” with a “ring” of Titanium beads, each with a magnetic core, which momentarily part to allow food to pass through, but close again thereafter, the closure force being enough to resist refluxing of contents.
It seems that dysphagia was the biggest safety concern that Torax’s clinical study had identified and about which the panel needed reassurance. According to the company’s submission, clinical findings suggested that 68% of patients had reported dysphagia events with 11% suffering on an ongoing basis. Apparently the panel was satisfied that the clinical benefit more than justified this risk, especially when alternative solutions included lifelong Proton-pump inhibitor therapy or the mush more invasive and anatomy-changing Nissen fundoplication procedure with its own attendant risk and side-effects.
One panelist, Steven D. Schwaitzberg, MD, from Harvard Medical School, Boston, Massachusetts stressed that while he applauded the efficacy of the device and its low complication rate, he would like to see postapproval studies lasting at least 10 years, stating ; “As an implant in the GI tract, our future is to understand what happens long-term.”
FDA approval of the device, while not a foregone conclusion, is a likely outcome in the near future.
If you’re a European clinician with experience of this device we’d love to hear from you.
Source: Medscape news