The US Food and Drug Administration’s (FDA) Orthopedic and Rehabilitation Devices Advisory Panel has voted strongly in support of the PreMarket Approval (PMA) application for Vertiflex’s Superion interspinous spacer system. The Panel voted that Superion demonstrated safety, effectiveness, and a favourable risk benefit profile based on the results from a 470 patient, multicentre, prospective and randomised controlled investigational device exemption trial.
“Superion demonstrated clinical success of >80% in all components of the composite primary endpoint. We will continue to work closely with the FDA to complete their review of our PMA while we finalise plans for commercialisation in the USA,” said Earl R Fender, president and chief executive officer of VertiFlex.
Pierce D Nunley, a study investigator from the Spine Institute of Louisiana, and Panel presenter commented: “The Superion interspinous spacer fits uniquely within the treatment continuum for patients who suffer from moderate lumbar spinal stenosis. Patients who have failed conservative care will have the option to receive a truly minimally invasive indirect decompression with Superion. This allows patients the potential to avoid traditional open spine surgery. Importantly, this can be performed without restricting options for future care.”
Scott L Blumenthal, spine surgeon at Texas Back Institute, and co-Medical Director for VertiFlex, also presented to the Advisory Panel. Blumenthal noted that, “in the investigational device exemption study, Superion demonstrated durability of effect beyond the 24-month primary endpoint, continuing through 36 months, and also performed comparably to what is reported in published literature on traditional decompression surgery. Thus Superion becomes a very viable treatment option for both surgeons and patients.”
The Superion interspinous spacer system is a minimally invasive spinal implant designed to treat moderate lumbar spinal stenosis. Superion is delivered through a cannula about the size of a dime and typically performed under local anaesthesia. Once in place, it is intended to reduce pressure on the affected nerves and allow patients to return to a more active lifestyle. Superion has been CE marked since 2007 and implanted in over 2,000 patients worldwide. It is currently an investigational device in the USA.