The Falena is an interspinous spacer indicated for surgical decompression in cases with spinal and radicular stenosis performed with a minimally invasive approach.The device is composed of two components:
- a winged structure, formed by a main pin with two wings at the extremities and a cap to allow for an atraumatic crossing of the interspinous ligament
- a “C” spring available in a range of height sizes (8-10-12-15mm)
Benefits:
- The peek “spring” gives an intrinsic elasticity to the device
- Preserves the supraspinous ligament
- Limits the extension of the symptomatic vertebral section Allows flexion, axial rotation, lateral bending
- Preserves of the mobility of of the symptomatic vertebral section
- The “C” spring heights are varied to allow the surgeon to best adapt spring for the desired distance from the two adjacent spinous processes, based on the patient’s unique spine anatomy
- The procedure is minimally invasive and performed under local anesthesia, preserving the mobility of the functional spinal unit
About Interspinous Devices
Interspinous spacers sometimes also called as Interspinous process decompression systems, are the devices implanted between vertebral spinous processes. These spacers are made up of a very strong but lightweight metal (titanium) which is biocompatible in the human body. These devices are imbedded in body to confine painful motion else enabling normal motion and to treat lumbar spinal stenosis, discogenic low-back pain, facet syndrome, disc herniations, and non-traumatic instability. Lumbar spinal stenosis is a thinning of the spinal canal in the lower back which causes compression on nerves and it is developed gradually with age. Radiology tests are used to confirm a diagnosis of moderate degenerative lumbar spinal stenosis. People with lumbar spinal stenosis experience pain but may also have weakness in their leg, lower back and buttocks, numbness, tingling.
The Interspinous spacer are implanted between those vertebrae in such a way that it prevents the patient from bending too far backward which causes pain by surgical procedure. The procedure is very small and sometimes patient can go home within a day.The increasing prevalence of spinal stenosis due to aging, arthritis, heredity and increased demand of surgical procedures that improved lifestyle and comfort will drive the Interspinous spacer market. The adoption of spacers are increasing due to low complication rate as compared to decompression and spinal fusion. The Interspinous spacers are widely used in geriatric population as per Medicare data due to old age patient are not comfortable with surgery due to their health conditions. Source:Transparency Market Research (TMR)
About Mikai
Mikai has been in the medical device field for almost 40 years producing and marketing products for traumatology, synthesis and correction of bones and joints specialties.The company was founded in 1978 with the ambition and spirit of challenge of medical device entrepreneurs who wanted to bring high-quality Italian products to the competitive orthopedic traumatology market. Achieving this challenge allowed Mikai to establish itself in the surgical medical device sector with: excellent quality products, a wide array of devices dedicated to TRAUMA, HAND, ORTHO, SPINE and FOOT, highly technical skills and attention to detail.
Strongly focused on the research and development of innovative and technological solutions, Mikai has three divisions: Research and Development, Production and Customer Service located in Genoa and Vicenza, Italy. The highly innovative spirit upon which Mikai was founded is the same that motivates us today, and is present in every single product we design, develop and manufacture.Mikai is involved in all phases of production. From laser scanning for 3D reproduction of internal project drawings presented from the technical office and CAD-CAM designs of the product to the manufacturing process ending in the machining plant, where man and technology work together to observe every detail and ensure the highest quality finished product.Company:www.mikai.com