VertiFlex said today that it won pre-market approval from the FDA for its Superion interspinous spacer for treating moderate lumbar spinal stenosis.
VertiFlex’s device is designed to be implanted in the spine through a minimally invasive procedure to relieve pressure, the company. Spinal stenosis is a narrowing of the spine, which can put pressure on spinal nerves. The condition, which is often associated with aging, can cause pain, numbness and loss of certain motor function.
The approval follows an FDA advisory panel recommendation in February that the device be approved, based on data from a 470-patient trial that showed a greater than 80% clinical success rate at 24 months.
"We are delighted with this PMA approval based on compelling level one evidence developed in the Superion IDE Trial. Superion has proven to be a safe, effective and least invasive solution for the treatment of spinal stenosis, in a mostly Medicare-aged population. Countless numbers of patients in the United States will now benefit from this important technological advancement," CEO Earl Fender said in a press release.
VertiFlex won CE Mark approval for the Superion in the European Union in 2007.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.