A Medical Device Daily
Atlas Spine (Jupiter, Florida) a spinal technology development company whose focus is on fusion and non-fusion products, reported the national launch of the Stature Vertebral Body Replacement System. The Stature VBR is a radiolucent MIS compatible spacer system designed to utilize a self-distracting technique in the treatment of various pathologies of the thoracic and lumbar spine.
"After significant developmental work and clinical evaluation, it is rewarding to see the enthusiasm toward Stature by an increasing group of clinicians. Their feedback and support drives our confidence in Statures performance as its use multiplies in surgeries across the nation," said President/CEO Bart Doedens.
The company said the Stature VBR is an "evolution" in the PEEK spacer arena. Spacer products have traditionally been met with the challenges of implanting an appropriately-sized device through a small access, the company said in a statement. These challenges often require more aggressive methods with compromised results.
The Stature VBRs geometry and self-distracting capabilities overcome these challenges, Atlas said, and "allow the surgeon to more easily and effectively restore the natural anatomic height and sagittal balance in severely compromised spaces."
The implants are manufactured from PEEK Optima, an implant-grade material with biomechanical characteristics similar to that of natural cortical bone. Polyether-etherketone (PEEK) is a hard radiolucent plastic that is used in conjunction with carbon-fiber reinforcement or as pure PEEK. Most manufacturers who use PEEK use radio marker dots so the surgeon can see where the implant meets the vertebral body endplate.
Atlas said some of the features and benefits of the device include a geometry designed for ease of insertion and distraction; tantalum markers placed to provide multi-planer radiographic perspective; counter rotation barbs for implant stability. They are available in a variety of sizes and geometric options to accommodate the patients specific anatomical requirements, but typically the size options range from 9 mm to 17 mm in height.
The Stature system is complemented by the Back-Pak DS, Atlas Spines comprehensive disc preparation set. MIS compatible as well, the Back-Pak DS includes proprietary instruments designed to maximize proficiency and provide optimum weight, balance, feel and control for surgeons. The company reported launch of this set in April (Medical Device Daily, April 8, 2008). The company said that the Back-Pak allows reduced invasiveness through accommodation of compromised disc space and preservation of bone.
Atlas Spine said that the Back-Pak DS supports its philosophy "that an efficient and successful surgery is significantly impacted by less-invasive instrumentation and techniques as well as the implants themselves."
Atlas makes spinal instruments and implants.
The company, which is named after the topmost vertebra that along with the Axis forms the joint connecting the skull and spine, is a privately held firm focused on the development and marketing of spinal instruments and implants.
Other products offered by Atlas Spine include the Verteview Cervical Plating System and Rebar VBR. Atlas also has received 510(k) clearances for the Apelo Pedicle Screw System, and the Rebar XL VBR is scheduled for release later this year.
Atlas was founded in 2001 by Matt Baynham, principal product designer, and Drs. Bret Baynham, Clay Baynham and Dave Campbell, all spine surgeons.