Issue link: https://beckershealthcare.uberflip.com/i/170082
Sign up for Becker's Orthopedic, Spine Business & Pain Management E-Weeklies at www.BeckersOrthopedicandSpine.com or call (800) 417-2035 lumbar fusion with interbody devices in order to treat degenerative conditions of the spine. The company plans to submit its Dymaxeon spine system to the FDA for 510(k) clearance. The Dymaxeon spine system, comprised of a rod and screw with hooks designed to fit and support the spinal column, will be geared towards addressing not only degenerative spine conditions, but trauma and neuromuscular issues as well. Back 2 Basics Spine believes in creating an affordable high quality system for hospitals and surgeons. Captiva Spine, based in Jupiter, Fla., is a medical device company that strives to place solutions for procedures in the hands of spine surgeons. Captiva Spine products include the CapLOXII spinal system, the FuseLOX lumbar cage, the Pivotec TLIF cage, the SmartLOX cervical plate system, the FuseLOX cervical cage and the TowerLOX spinal system. In 2011, the Pivotec TLIF device, a controlled pivotal delivery system, was awarded a patent and the CapLOXII spinal system received FDA 510(k) clearance. The TowerLOX spinal system, a cannulated pedicle screw system, received FDA clearance in 2012. Centinel Spine, based in New York and West Chester, Pa., is a biomechanics company that works to translate surgeons' ideas into products that can be effectively used in the field of spine surgery. The company's products include the Stalif TT, the Stalif C and the Stalif Midline. Each product has undergone a biomechanical study to ascertain its efficacy. The biomechanical studies of the Stalif TT and the Stalif C found that each functioned well as a truly stand alone device. The Stalif Midline was designed to avoid posterior surgery, create stable fixation, and restore disc height and to be MRI compatible. The biomechanical study of the Stalif Midline compared its flexibility to that of Centinel Spine's Stalif TT and found the two devices to be on equal footing. Centinel Spine prides itself on basing its products on biomechanical principles, rather than ease of use alone. Choice Spine, based in Knoxville, Tenn., is a spinal technology company that aims to work with orthopedic and spine surgeons to create the products they need. The company holds a number of patents and produces devices that are designed to treat six different spine conditions. Choice Spine's cervical spine products include the FALCON and the STEALTH Cervical Fusion Devices. The company also has two thoracolumbar products, a device designed to treat patients with scoliosis, an anterior spinal clip system and several lumbar products. One of the company's newest products is the STARFIRE Pedicle Screw System. Globus Medical is an Audubon, Pa.-based spinal implant manufacturing company with minimally invasive, motion preservation, cervical intervertebral fusion, thoracolumbar and bio- materials products. For the year 2012, the company's sales were $386 million, up 16.4 percent from the previous year. Net income increased from $60.8 million in 2011 to $73.8 million in 2012, a 21.5 percent increase. Globus Medical is currently conducting several clinical trials. The company just completed a study of their TRIUMPH Lumbar Disc, a cobalt chrome alloy articulating disc intended for reconstruction of the spinal disc. Invibio, based in West Conshohocken, Pa., provides biomaterial solutions to the medical device market. The company offers biocompatible polymers including PEEK-OPTIMA polymer and compounds, MOTIS polymer, ENDOGLIN composite and PEEK-CLASSIX polymer. Invibio biocompatible polymers have been used in devices such as the OSIMPLANT ARAMIS surgical disc prosthesis, Aesculap EnduRo Rotational Knee System and Kelyniam Global Custom Skull Implants. In 2009, Invibio's PEEK-OPTIMA biomaterial received a Spine Technology Award for its innovation in the biomaterial field. K2M, based in Leesburg, Va., is a medical device company concentrated on creating solutions for complex spinal treatments and procedures. The K2M product line includes solutions for spine deformity, trauma, tumors and degenerative lumbar conditions. The company also manufactures minimally invasive devices, cervical devices, interbody devices and biologics. K2M also offers platform technologies including MESA Technology, RANGE Complex Spine Technology, tifix Locking Technology and Rail 4D Technology. K2M has additional offices in the UK, Germany, Austria and Switzerland. In 2012, the company introduced their product portfolio to the Italian market. Lanx, based in Broomfield, Colo., is a medical device company that aspires to work with spine surgeons to produce efficient products that better patient outcomes in fixation and fusion procedures. The company recently added the Timberline Lateral Fusion System, the Epic Anterior Thoracolumbar Plate, the Durango Stand-Alone ALIF System and the Concero Facet Screw System to its product line, which already contained biologics, several different systems and a number of different spacers. In 2012, Lanx was granted a patent for the minimally invasive ASPEN Fusion System and announced the results of a clinical study that found a 94 percent fusion rate with the ASPEN system. LDR, based in Austin, Texas, is a company geared towards creating technology for spinal procedures. LDR's products include the ROIC Cervical Cage, ROI-A ALIF Cage, ROI-A Oblique ALIF Cage and Avenue L Lateral Lumbar Cage. The products are designed for long term stability and easy insertion. Four LDR products have received FDA clearance within 35 the past two years. LDR has headquarters in France, South Korea and Brazil and a regional office in China. Life Spine, a company based in Hoffman Estates, Ill., develops, manufactures and markets products that are intended for minimally invasive spine surgery. The Life Spine product portfolio includes anterior and posterior cervical, thoracolumbar and interbody products. The company recently announced the limited release of the CENTRIC Lateral Retractor System, which offers controlled blades and an open frame for optimal visual access during lateral approach spine surgery. Mazor Robotics, based in Orlando, creates robotic guidance systems designed to aid in surgeons in performing spine surgery. The company's premier product is the Renaissance surgical system, which was developed for maximum precision and safety. Thus far, the Renaissance system has been used by surgeons to place over 15,000 implants. The system can be used in conjunction with spinal procedures including biopsies, pedicle screws, osteotomies, spinal deformity correction and a number of thoracolumbar approaches. Mazor Robotics also aims for the Renaissance system to be used in minimally invasive procedures, to lessen radiation exposure for patients and to produce consistent, optimal results. A clinical trial found the system to provide 98.3 percent accuracy in a study of 3,271 implants in 635 cases. NLT Spine is a device company that works to provide the spine industry with non-linear spinal solutions. NLT Spine is headquartered in Israel and opened a U.S. office in Dedham, Mass., in January 2013. The company focuses on minimally invasive solutions and has a product portfolio of issued and patent-pending devices designed to treat degenerative spinal conditions. The PROW FUSION, designed for TLIF procedures, is designed to allow more bone graft volume within the implant than allowed by current devices. The PROW FUSION is the first clinical application of the company's non-linear technology platform that has been introduced to the U.S. The company plans to build on that platform and provide products that address several spine pathologies. NLT's discectomy system, eSPIN, is the company's most recent product to receive FDA 510(k) clearance. NuVasive, based in San Diego, is a medical device company that develops minimally invasive spine products and procedures, including the eXtreme Lateral Interbody Fusion system, which opened the door to lateral approach spine surgery. The company's product line includes over 75 products. NuVasive offers lumbar products, thoracic products, cervical applications, neuromonitoring services and a line of biologics. NuVasive and the Society of Lateral Access Surgery are currently sponsoring a clinical trial

