Spineology system gains FDA de novo status

Spineology this week announced it received an FDA de novo grant for its minimally invasive […]

Spineology this week announced it received an FDA de novo grant for its minimally invasive OptiMesh Expandable Interbody Fusion System.
The grant follows the successful completion of its Spineology Clinical Outcomes Trial investigational device exception trial. The data showed substantial improvements in lower back pain and a reduction in functional limitations at six, 12 and 24 months. It also showed a 98% fusion rate at 24 months and 90% excellent or good patient satisfaction scores at six, 12 and 24 months.
OptiMesh is a mesh device that expands in three dimensions to allow surgeons to perform interbody fusion procedures through a small access in the spine industry.
“We have found this innovative, minimally invasive device to be a safe and effective option for lumbar interbody fusion procedures,” Dr. John Chi, the trial’s lead investigator, said in a news release. “The outcomes, including high fusion rates, improved function, reduced pain and high satisfaction rates, are very favorable. Additionally, the minimal exposure requirements yielded an exceptional safety profile.”
Spineology said it is preparing for a launch of the OptiLIF procedure using the OptiMesh device during the first quarter of 2021. The de novo grant allows the company to commercialize the OptiLIF procedure to support Spineology’s anatomy-conserving product strategy.
“I am pleased to announce the De Novo grant of our OptiMesh implants and instrumentation to support the OptiLIF procedure. Based on the strong SCOUT study results and experiences of our investigators, we are preparing for a full market launch in Q1 of 2021. I anticipate OptiLIF will help take surgery for low back and leg pain to the next level through its ability to provide excellent patient outcomes, enhanced recovery and exceptional efficiency,” CEO John Booth.

Original Article: (http://feedproxy.google.com/~r/MedicalDesignAndOutsourcing/~3/MWKqtksWE4A/)