OptiMesh Expandable Interbody Fusion System Receives FDA De Novo Grant Reports Spineology

Novel OptiLIF™ Procedure Expected to Launch in Q1 2021

Spineology Inc., an innovator in anatomy-conserving surgery, is excited to announce the FDA grant of its proprietary Spineology Interbody Fusion System, now called the OptiMesh Expandable Interbody Fusion System. The grant follows the successful completion of the SCOUT (Spineology Clinical Outcomes Trial) Investigational Device Exemption (IDE) trial. OptiMesh is a unique mesh device that expands in three dimensions, enabling surgeons to perform interbody fusion procedures through the smallest access in the spine industry.

Spineology notes the SCOUT IDE trial outcomes data was presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Meeting in November 2019, by the trial’s lead investigator, John Chi, M.D., M.P.H. Dr. Chi is Director of Neurosurgical Oncology at Brigham and Women’s Hospital in Boston, Massachusetts, and Associate Professor of Neurosurgery at Harvard Medical School. Dr. Chi and his co-authors reported:

  • Substantial improvements in low back pain and a reduction in functional limitations at six, 12, and 24 months
  • A 98 percent fusion rate at 24 months, as seen on CT scans assessed by two independent radiologists
  • ~ 90 percent “Excellent” or “Good” patient satisfaction scores at six, 12, and 24 months post-procedure
  • An excellent safety record with no serious, device-related, adverse events

“We have found this innovative, minimally invasive device to be a safe and effective option for lumbar interbody fusion procedures,” said Dr. Chi. “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 is preparing for a Q1 2021 launch of the OptiLIF procedure utilizing the OptiMesh device. This procedure enables enhanced recovery and exceptional efficiency, and its outcomes are supported by prospective FDA IDE clinical data.

“OptiLIF is the least invasive lumbar fusion procedure that I can do,” said Dr. Stephane Lavoie of DeLand, Florida, an investigator in the SCOUT study. “The unique OptiMesh implant can be inserted through a one-centimeter incision and then expanded to restore anatomy, which provides neural decompression and optimally conforms to a patient’s endplates. As a result, patients recover quickly, and the impact to procedure efficiency is significant. OptiLIF will have a major impact on the standard of care related to low back and leg pain.”

The FDA De Novo grant of the OptiMesh Expandable Interbody Fusion System opens the door to commercialization of Spineology’s OptiLIF procedure, which supports 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,” said John Booth, Spineology’s CEO.

 

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Kleiner Device Labs will attend the meeting and looks forward to demonstrating the new KG®2 Surge® flow-thru interbody system to surgeons
“Medtronic is continuing our efforts to stop Axonics from profiting off of their unauthorized use of our innovations and intellectual property," said Mira Sahney, president of the pelvic health business in the neuroscience portfolio at Medtronic. "The pattern is clear: Axonics uses Medtronic technologies to improperly compete in the market. It is time for Axonics to be held accountable for these unlawful acts."
The addition of Frank J Veith, MD to the Board underscores ViTAA's commitment to excellence and innovation in the development of medical technologies. His vast experience and achievements will provide critical insights and direction as ViTAA continues to pursue its goal of revolutionizing patient care through cutting-edge solutions.
Ultralife Corporation will join forces with cart manufacturer Karta to launch a complete medical cart and power solution on booth 1237 (Hall A) at HIMSS, from March 12-14, 2024 at the Orange County Convention Center in Orlando, Florida.
“It’s exciting to be one of the first two hospitals in Europe to use Stryker’s Mixed Reality Guidance System,” said Professor Berhouet. “I am also pleased to be leading a pilot study to investigate the safety and effectiveness of this new technology, alongside three other centres in France.”

By using this website you agree to accept Medical Device News Magazine Privacy Policy