SPINAL SIMPLICITY CLAIMS FIRST FDA CLEARANCE USING PERCUTANEOUS LATERAL APPROACH (Orthopedics This Week)
Overland Park, Kansas-based Spinal Simplicity, LLC, claims it has the only ISP (interspinous process) fusion device utilizing a percutaneous lateral approach to the spine cleared by the FDA for U.S. patients.
On January 9, 2015, the company announced the 510(k) FDA clearance of its Minuteman lateral percutaneous interlaminar fusion device.
The Minuteman
The device, according to the company, is a “pre-packaged sterile supplemental posterior fixation system” which offers a “minimally invasive alternative to traditional pedicle screws and other spinous process plates” placed in open procedures for the treatment of degenerative disc disease, spondylolisthesis, tumors and/or trauma. The system can be placed in patients utilizing two minimally invasive approaches to the spine, posterior unilateral or “lateral percutaneous (PercLIF-Percutaneous Lateral Interlaminar Fusion).”
While the company used several ISP fusion devices as predicate devices to gain FDA 510(k) clearance, Carlos Gonzalez, the company’s director of sales and marketing, told OTW that Lanx’s (Biomet, Inc.) Aspen device was used as the main predicate.
The PercLIF approach and instrumentation provide a way of “quickly and accurately placing the Minuteman between the spinous processes through a one-inch incision. This technique eliminates the lateral dissection of sensitive back muscles often associated with lumbar fusions while maintaining an adequate distance from the neural structures,” said the company.
Todd Moseley, a co-founder of the company said the lateral approach is “one of the many” potential benefits of the Minuteman system. “Direct lateral surgeons will now have the ability to insert a supplemental posterior fixation device with the patient remaining in the lateral decubitous position, typically in about 10 to 15 minutes. As a team, Spinal Simplicity believes this flagship product will provide the foundation for further innovation in the minimally invasive spine market.”
The company anticipates commercial launch of the Minuteman system in the first quarter of 2015. The company began selling the product in Europe in 2011 after receiving a CE Mark.
Spinal Simplicity was founded in 2008 by Moseley and Harold Hess, M.D., a neurosurgeon. The company says it dedicated to creating “innovative” and “simple” solutions for complex problems.