Becker's Spine Review

28 Spine Device & Innovation ogy analyzes conductivity of surrounding tissue and alerts surgeons when they make contact with soft tissues to prevent vertebral cortex perforation. Around 300 surgeons use PediGuard on a regular basis — about 100 sur- geons in the United States — and 20 percent of U.S. spine surgery institu- tions have adopted the technology. The technology can also reduce physician radiation exposure; studies have shown physicians that use PediGuard expe- rienced a 73 percent radiation reduction time and 51 percent reduction in thyroid radiation exposure to the surgeon. PEEK-OPTIMA (Invibio). PEEK-OPTIMA is the original PEEK biomaterial that is now used in several spine products, with almost 70 percent of the in- terbody device market. Invibio first pioneered the use of PEEK-OPTIMA in medical devices around 15 years ago and devices using PEEK have received FDA clearance for use in several implantable applications, including discs, spi- nal rods and interspinous devices. Invibio has now developed a new material — PEEK-OPTIMA HA Enhanced — that incorporates Hydroxyapatite, which is used to improve bone apposition to metal devices such as titanium pedicle screws. The company also shifted its brand strategy last year to more closely align with the market they serve — including spine, trauma and orthopedics. Pegasus Anchored Cervical Interbody (Alphatec Spine). Alphatec Spine showcased its new anchored, cervical interbody device — Pegasus — at the 2013 North American Spine Society Annual Meeting. Pegasus delivers the spacer with an integrated anchoring mechanism in a single-step, non-impac- tion implantation is designed to reduce operative time. The device's design also allows for simple intraoperative and postoperative removal if necessary. The device received FDA clearance in January 2013, along with the compa- ny's minimally invasive system ILLICO FS Facet Fixation System. SureScan (Medtronic). The SureScan System is the first pain neurostimula- tion system FDA-approved for patients to safely undergo an MRI without first removing the system, which represents a huge leap forward in back pain technology. SureScan was designed with the shielded Vectris lead to reduce the risk of thermal tissue damage by dispersing radiofrequency energy along the entire length of the lead. Protective technology also prevents the radio- frequency energy from entering the device. Patients are able to turn off the device and disable the neurostimulation, thereby making it MRI safe. Ac- cording to a MarketsandMarkets report, the neuromodulation device market is poised to expand to $6.8 billion by 2017. VariLift-C Standalone Expandable Interbody Fusion System (Wenzel Spine). The VariLift-C Standalone Zero-Profile Expandable Cervical Interbody Fusion Device was launched in April 2013. The company announced the system re- ceived FDA clearance in February 2013 with the indication for implantation as a single device or bilaterally via an anterior approach, which may be im- planted without supplemental fixation. Feedback from the initial five clinical sites showed VariLift-C provided a streamlined ACDF procedure without sup- plemental fixation. The device also allows surgeons to treat adjacent segment disease without needing to remove and replace previous constructs. XLIF ACR (NuVasive). The XLIF ACR and the CoRoent XL-Hyperlordotic Implants used in conjunction with the procedure have FDA 510(k) clear- ance. Approximately 100 physicians have used the XLIF ACR procedure with CoRoent XL-Hyperlordotic Implants, intended for use at either one- or two- contiguous levels in the lumbar spine for patients with degenerative disc disease with up to Grade I spondylolisthesis. The system allows surgeons to address patients with global sagittal imbalance via the anterior column with a minimally disruptive technique. The procedure also potentially decreases or eliminates the need to perform extensive posterior osteotomies that could lead to less blood loss, shorter operating room time and reduced hospital stays as well as fewer perioperative complications than traditional fusions. Luiz Pimenta, MD, Behrooz Akbarnia, MD, and Blake Rodgers, MD, were instrumental in the system's design. Zeus Oblique Lateral Lumbar Interbody Device (Amendia). The Zeus Oblique Lateral Lumbar Interbody Device is constructed of PEEK and in- cludes tantalum radiopaque markers to optimize visibility and placement. Amendia's patented cannulas are designed to help safely guide the implant past the nerve root and the entire system was designed to minimize operat- ing room time. OLLIF allows for a pathway where the interbody part of the procedure can be done laterally without removing any bone. This procedure can be done in the outpatient ambulatory surgery center setting because very little tissue damage is associated with the procedure. n Global Medical Device Market Growth updates By Laura Miller Here are four medical device industry reports released in early 2014: • The spine surgery device market is expected to be worth $14.8 bil- lion by 2017. The market was valued at $11.6 billion in 2012 and is expected to grow at a compound annual growth rate of 5.1 percent through 2017, according to a MarketsandMarkets report. • The biomaterials market is estimated to reach $88.4 billion by 2017. It was valued at $44 billion in 2012 and poised to grow at a com- pound annual growth rate of 15 percent through 2017, according to a MarketsandMarkets report. • The sports medicine market is expected to reach $8.3 billion by 2019. The market was valued at $6.1 billion in 2012 and expected to grow at a compound annual growth rate of 4.4 percent through 2019, ac- cording to a Transparency Market Research report. • The minimally invasive vertebral compression fracture repair market is expected to reach $2.82 billion by 2019. The market was valued at $1.58 billion in 2012 and is expected to grow at a compound annual growth rate of 8.7 percent to 2019, according to a Transparency Mar- ket Research Report. n LDR Holding Corporation is a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders. LDR's primary products are based on its exclusive VerteBRIDGE® fusion and Mobi® non- fusion technology platforms and are designed for applications in the cervical and lumbar spine. These technologies enable products that are less invasive, provide greater intra-operative flexibility, offer simplified surgical techniques and promote improved clinical outcomes for patients as compared to existing alternatives. LDR recently received approval from the U.S. Food and Drug Administration (FDA) for the Mobi-C® cervical disc replacement device, the first and only cervical disc replacement device to receive FDA approval to treat both one-level and two-level cervical disc disease. For more information regarding LDR, visit www.ldr.com or www.cervicaldisc.com.

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