Becker's Healthcare would like to recognize the following 16 spine devices with the 2014 Spine Device Award. Devices are recognized for their contribution to advancing spine technology and patient care. Devices included represent both the cutting-edge and gold standard in spine care.
The devices are listed in alphabetical order. This list is sponsored by LDR.
AIM Minimally Invasive Surgery System (SpineCraft). SpineCraft launched the AIM Minimally Invasive Surgery System in April 2012 after early procedures were a success. The company received positive feedback from surgeons performing the procedure, who were particularly pleased with the instrument performance and small incision required. SpineCraft is a United States-based, privately-held medical device company founded in 2004 by medical professionals. Their surgeon advisory board includes Kamal Ibrahim, MD; Steven Mardjetko, MD; Steven Mather, MD; Anis Mekhail, MD; and Youssry El-Hawary, MD.
BoneBac MIS Interbody Fusion System (Thompson MIS). After surveying physicians, Thompson MIS found one of the biggest challenges for surgeons performing minimally invasive posterior lumbar fusions — compared with open procedures — is packing the disc space with graft; the company sought to solve this problem with the BoneBac MIS Interbody Fusion System. The patented TLIF and PLIF system is designed for direct, controlled graft material injection in situ while the inserter is still attached. The surgeon can achieve a graft packed, void-free disc space without using accessory funnels and with fewer instrument passes by the nerve root. Surgeons can use a variety of graft materials — including local autograft — for the procedure. The system was studied among 400 spinal procedures and surgeons found a 94.3 percent fusion rate 10 months after surgery, and most patients did not require additional bone graft extender.
coflex (Paradigm Spine). The coflex Interlaminar Technology is indicated for use after decompression for one- or two-level lumbar stenosis. The device consists of a single, U-shaped component made from medical-grade titanium alloy biocompatible and x-ray visible. The bone-facing surfaces are ridged to resist migration. In the IDE study, patients who underwent surgery with the coflex device maintained foraminal height 24 months out, and the coflex patients outperformed fusion patients in Oswestry Disability Index scores. The device can be used during hospital and outpatient ambulatory surgery center procedures. There were shorter hospital stays, quicker recovery times and greater mobility at the treatment level after undergoing this fusionless surgery when compared with fusion procedures.
EXPAREL (Pacira Pharmaceuticals). EXPAREL is a liposomal formulation of bupivacaine indicated for use at the surgical site to produce postsurgical analgesia. One administration can reduce pain and opioid requirements up to 72 hours and the formulation is flexible to cover the surgical site. As a result, EXPAREL can be used in minimally invasive or open procedures. The product has been used in a variety of procedures, including lumbar and cervical interbody fusions, microdiscectomies and laminectomies, and can assist in early ambulation. The product can also serve patients who are opioid tolerant and would otherwise risk over-sedation to control pain.
Hero Allograft (Spinal Elements). The Hero Allograft was introduced in November 2012 as Spinal Elements' first allograft tissue product, made to honor those who donated the tissue. While many companies profit from allograft sales, Spinal Elements took a different route; the company developed the "Pledge to be a Hero" program around the Hero Allograft and donates all profits from the product's sale to charities benefiting children with life-threatening medical conditions. The product consists of various configurations of human allograft tissue, including demineralized bone matrix in paste or putty form, compressible cancellous blocks and strips, and structural grafts. The grafts are typically used for infusion procedures.
iFuse Implant System (SI-BONE). More than 10,000 procedures have been performed using the iFuse Implant System for minimally invasive sacroiliac joint fusion. Around 700 surgeons are trained in the procedure and nine clinical studies examine its effectiveness. A multi-center comparison between iFuse and open SI joint fusion showed patients who underwent the less invasive procedure experienced significantly greater pain relief and favorable perioperative surgical measures. The implant was designed and coated to stabilize and fuse the heavily loaded SI joint. It includes rigid titanium constructs and a large implant surface area.
LATIS (Globus Medical). Launched in June 2013, the LATIS minimally invasive lumbar interbody fusion spacer is designed for patients with degenerative disc disease. The implant can be inserted through the minimally invasive transforaminal lumbar interbody fusion approach and expands laterally to provide a footprint and graft volume equivalent to an anterior lumbar interbody fusion spacer or lateral lumbar interbody fusion spacer. The system includes customized disc preparation and sizing instruments to simplify procedures as well as a variety of footprints, heights and lordotic configurations for customization.
MESA Technology (K2M). K2M's low-profile MESA spinal system features Zero-Torque Technology and 60 degree range of motion. The system is designed for the surgeon to perform a one-step lock without torsional stress applied to the spine. The system is used for less invasive deformity correction and received pediatric clearance for the procedure in 2012. K2M has been growing immensely over the past few years with its mission to provide less invasive systems for complex spinal cases, and in March 2014 the company filed for an initial public offering to up to $100 million in common shares.
Mobi-C (LDR). LDR received FDA approval to use the Mobi-C Cervical Disc for one-and two-level spinal disc replacement procedures in August 2013. It was the first cervical disc approved for both one- and two-levels. The cobalt chromium alloy and polyethylene implant is a mobile-bearing prosthesis designed for bone-sparing, cervical intervertebral disc replacement. During the one-level IDE trial, Mobi-C demonstrated non-inferiority when compared with anterior cervical discectomy and fusion with a 73.7 percent success rate, compared with 65.3 percent among ACDF patients. Fewer patients in the Mobi-C group also reported negative radiographic changes from baseline in adjacent segments than the ACDF group. The disc showed similar success rates for two-level disc replacement when compared to fusion — 69.7 percent compared with 37.4 percent in the ACDF group.
PediGuard (SpineGuard). More than 30,000 procedures have been performed worldwide using PediGuard for pedicle screw placement. SpineGuard's PediGuard is a wireless, handheld device that can detect possible vertebral cortex perforation during pedicle screw placement. The technology 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 surgeons in the United States — and 20 percent of U.S. spine surgery institutions have adopted the technology. The technology can also reduce physician radiation exposure; studies have shown physicians that use PediGuard experienced 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 interbody 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, spinal 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. 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-impaction 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 company's minimally invasive system ILLICO FS Facet Fixation System.
SureScan (Medtronic). The SureScan System is the first pain neurostimulation 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 radiofrequency energy from entering the device. Patients are able to turn off the device and disable the neurostimulation, thereby making it MRI safe. According 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 received FDA clearance in February 2013 with the indication for implantation as a single device or bilaterally via an anterior approach, which may be implanted without supplemental fixation. Feedback from the initial five clinical sites showed VariLift-C provided a streamlined ACDF procedure without supplemental 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) clearance. 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 includes 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 operating 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.
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