Spineology Wins FDA Clearance For Rampart Duo Implant Device
Oakdale-based spinal technology developer Spineology said Wednesday that its unique implant device, the Rampart Duo, received clearance from the U.S. Food and Drug Administration.
The Rampart Duo, which is used to maintain sagittal alignment (or a front-to-back imbalance in the spine) during surgery, also received praise by medical professionals.
“The implant design allows for decreased retraction requirements when compared to current interbody systems,” said Sandeep Kunwar, a doctor from San Francisco. “The minimized tissue retraction may reduce the potential for nerve damage and resultant leg pain associated with the lateral approach.”
Moreover, Austin, Texas-based Dr. Craig Kuhns believed the Rampart Duo “may help preserve patient anatomy and limit operating room time.”
The device is said to be the first of its kind to combine titanium, PEEK (otherwise known as polyether ether ketone), and graft containment mesh elements.
“The 510(k) clearance of Rampart Duo opens the door to the commercialization of a family of hybrid PEEK and graft containment mesh implants designed for interbody fusion,” said Spineology CEO John Booth in a statement. “The implant is a great addition to our anatomy-conserving product offering.”
Furthermore, the market clearance of the Rampart Duo could prove complimentary to a deal Spineology made in September with the Musculoskeletal Transplant Foundation. Spineology is now the New Jersey nonprofit’s sole tissue provider for its allograft product lines.