Noblesville, Ind.-based Nexxt Spine unveiled an ISO Class 10,000 Certified Cleanroom for pre-packaging sterile spinal implants in its manufacturing and corporate headquarters.
Here are four things to know:
1. A study published in The Spine Journal analyzed 105 spine surgeries. Those spinal implants sterilized in line with a validated hospital protocol still had a contamination rate of 16.7 percent. One percent to 15 percent of spine surgery patients will experience a postoperative spine infection.
2. Nexxt Spine President Andy Elsbury commented, "Pre-packaged sterile implants do not require disinfection and steam sterilization prior to use. Implants are individually wrapped in a peel pack tray and sterilized using electron beam radiation."
3. The company plans to launch its pre-packaged sterile implant initiative in line with the expected FDA clearance of its Nexxt Matrixx.
4. The Nexxt Matrixx is a 3D-printed, porous, titanium line of intervertebral spacers, intended for spinal fusions.