Mikai, S.p.A. ®, a privately held medical device company, announced the market launch of its patented Falena® Interspinous Decompression Device. Falena®, a small titanium and PEEK implant inserted during minimally invasive back surgery, treats lumbar spinal stenosis (LSS) providing patient pain relief.
LSS is a narrowing of the spinal canal in the lower back that can irritate the nerves that branch from the spinal cord and is most often a result of aging and everyday wear on the spine commonly occurring in people over age 50. LSS may cause progressive low back pain with or without radiation, numbness or weakness in the buttocks and legs and symptoms that improve with resting, lying down or bending forward.
“Using local anesthesia, we found the Falena® procedure simple and straightforward. The initial post-surgery results are excellent with spinal decompression and flexion preservation achieved and almost immediate patient pain relief,” according to Prof. Giovanni Simonetti and Prof. Salvatore Masala of University Hospital Tor Vergata in Rome, Italy.
The patented Falena® device is a winged structure manufactured in titanium with a “C” shaped spacer in PEEK OPTIMA® to extend a rigidity and elasticity similar to bone with high biocompatibility and wear resistance.
The Falena® procedure is an alternative to spinal fusion and is typically performed in less than an hour under local or general anesthesia using dedicated instrumentation. The procedure is reversible with an average recovery time from two to seven weeks. Falena® limits the extension of the spine at the symptomatic levels and preserves flexion, axial rotation, lateral bending and mobility of the symptomatic vertebral section. Falena® is positioned in and preserves the interspinous ligament which contributes to the equilibrium and stabilization of the spine.
Falena®, currently not available for sale in the U.S., will be exhibited at the American Academy of Orthopedic Surgeons meeting in Las Vegas, NV, February 25-28 at booth #1330, Hall A.
Source: Mikai, S.p.A.