30 minimally invasive spine devices to know | 2017 Featured

By  Laura Dyrda | Sunday, 05 November 2017 18:34
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 Minimally invasive spine surgery is becoming more common as technological advancements in surgical procedures and pain management make less invasive surgery safer and more effective than traditional open procedures.

 Here are 30 minimally invasive spine devices and companies to know.

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Allen Medical is an industry leader in patient positioning and surgical site access. Our passion is improving patient outcomes and caregiver safety while enhancing our customers’ efficiency. We strive to provide innovative solutions to address our customers’ most pressing needs. By immersing ourselves in our customers’ world, we are able to better address these needs and the daily challenges of their environment.

 

Note: Companies do not pay and cannot pay for placement on this list. Devices are listed in alphabetical order. For questions or comments, please contact Laura Dyrda at ldyrda@beckershealthcare.com.

 

Advance Table L2P Platform (Allen Medical). The Advance Table L2P Platform is designed for minimally invasive lateral spine surgery patient positioning. The system works with Allen Medical's Allen Advance Table to deliver lateral flex up to 32 degrees and quick rotation directly from the lateral to the prone position through manual rotation. L2P could reduce the number of staff required for repositioning and eliminate the need to transfer patients from one table to another.

AxiaLIF (TranS1). The AxiaLIF procedure allows surgeons to perform reproducible anterior retroperitoneal pre-sacral access routes to the L5-S1 vertebral bodies. With more than 85 published research studies supporting its use, AxiaLIF has a shorter procedure time and results in less blood loss on average than TLIF, PLIF and ALIF approaches. TranS1 also conducted an economic study, released in 2015, which found AxiaLIF reduced the cost per procedure for L5-S1 fusions by $3,500 when compared with TLIF procedures through shortened hospital stays, lower readmission rates and faster return-to-work for patients.

Avenue T TLIF Cage (Zimmer Biomet). Zimmer Biomet launched the Avenue T TLIF Cage with integrated VerteBRIDGE plating in the U.S. on Oct. 2. The system facilitates simplified cage insertion and zero-profile, intradiscal fixation through the direct minimally invasive surgical approach. Avenue T is the first posteriorly implanted cage with integrated, anti-migration fixation, and is indicated for intervertebral body fusion from L2 to S1 in skeletally mature patients. The cage and VerteBRIDGE plates can be simultaneously loaded on the inserter and, once implanted, surgeons can advance both at the same time to reduce implantation steps.

Battalion Lateral System (Alphatec Spine). Alphatec Spine launched the Battalion Lateral System with the Squadron Retractor as a minimally invasive lateral access procedure in April. The Battalion system is a next-generation lateral system that reduces tissue creep, minimizes psoas retraction time, and aims to achieve alignment and fusion objectives. The system's design allows surgeons to customize access to match the patient's unique anatomy through independent retraction of the cranial and caudal blades. Battalion was Alphatec Spine's introduction into the $500 million U.S. lateral market.

Coflex (Paradigm Spine). The coflex Interlaminar Technology is a stabilization device indicated for use in one- or two-level procedures for lumbar spinal stenosis from L1-5. With more than five years of long-term, Level 1 data proving the procedure is effective when compared to fusion, coflex received a boost when the International Society for the Advancement of Spine Surgery issued a policy statement recommending coverage of decompression with interlaminar stabilization in December 2016. Payers took notice, with Blue Cross Blue Shield of Michigan Medical Policy becoming the first commercial payer to issue positive coverage for coflex in September 2017. Surgeons in more than 40 countries now use the technology to treat patients worldwide in the inpatient and outpatient settings.

Dreal (Carevature Medical). Dreal is a curved device designed to cut bone in all sections of the spine and could improve access to the foramen. A relatively new device — it's been used in around 550 patients worldwide — Dreal spinal decompression and bone removal system has been used in over 60 successful commercial lumbar and cervical procedures at Baylor Scott & White Medical Center in Frisco, Texas. Surgeons performing those procedures are optimistic; John Peloza, MD, one of the initial surgeons using the technology, reported shorter decompression time and maximum healthy tissue preservation when using Dreal in cervical and lumbar cases.

Endoskeleton Next Generation nanoLOCK Surface Technology (Titan Spine). The next generation nanoLOCK surface technology is used in Titan Spine's full line of Endoskeleton interbody devices and designed to increase the osteogenic response. Titan's nanoLOCK was the first FDA-cleared interbody device to feature nanotechnology, a proprietary blend of textures at the macro, micro and cellular levels. Fully launched in the U.S. in 2016, the Endoskeleton titanium implants with nanoLOCK surface technology have been used at more than 14 hospitals and received a new technology code from CMS. The company's sales grew 51 percent as a result of the launch, and Titan saw rapid surgeon adoption nationwide.

ExcelsiusGPS (Globus Medical). The first spine surgeries using Globus Medical's ExcelsiusGPS system were performed in October at Johns Hopkins Hospital in Baltimore and St. Mark's Hospital in Salt Lake City. Designed to take typical surgical workflow into account and facilitate procedural efficiency, the robotic system combines surgical navigation and robotic guidance for spinal procedures to improve accuracy and reduce radiation exposure. ExcelsiusGPS supports minimally invasive and open screw placement and integrates with Globus Medical implants and instruments.

Everest Minimally Invasive XTower (K2M). K2M launched the Everest Minimally Invasive XTower instrumentation globally in September as an enhancement to the Everest MI XT Spinal System, originally launched last year. The percutaneous screw platform provides a new surgical solution to treat complex deformities with a less invasive approach and achieve 3D spinal balance. XTower instrumentation includes entire tab-to-screw assembly and can be used throughout the procedure with streamlined instrumentation. Surgeons can treat the full spectrum of pathologies with the single system.

iFuse (SI-Bone). iFuse is SI-Bone's minimally invasive sacroiliac joint fusion system, which has been used in more than 28,000 procedures since 2008. Over the past half-decade, several Medicare Advantage, Tricare and commercial payers including Blue Cross Blue Shield plans, have approved coverage of the iFuse Implant System. In January 2017, SI-Bone rolled out a warranty program for the implant, guaranteeing the product and results with a promise to supplement or replace the implant within one year of the initial procedure if revision is required. More than 50 peer-reviewed studies have been conducted on iFuse, with positive results.

FLXfit 3D Expandable TLIF Cage (Expanding Orthopedics). The FLXfit is an expandable, articulated interbody fusion device surgeons can use in conjunction with supplemental fixation in skeletally mature patients after total or partial discectomy. The titanium cage articulates laterally and expands in height to enable larger footprint support and disc height restoration. The technology can be used with the MIS FLXfit Inserter, designed to fit through a narrow access tube and maintain a clear line of sight for visualization through the microscope.

Lamellar 3D Titanium Technology (K2M). The Lamellar 3D Titanium Technology uses an advanced three-dimensional printing method to create unique structures that aren't possible with traditional manufacturing techniques. The implants are grown through selective application of a high-energy laser beam on titanium powder to incorporate porosity and surface roughness associated with bone growth activity. K2M received FDA clearance in June for the Mojave PL 3D Expandable Interbody System featuring the Lamellar 3D Titanium Technology, and became one of the first companies to market 3D-printed titanium interbody devices.

LessRay (NuVasive). NuVasive commercially launched the LessRay in September 2017. The system uses a proprietary software algorithm and hardware components to reduce radiation exposure in hospital operating rooms, focused on minimally invasive spine procedures. The image enhancement platform takes low-quality, low-dose images and enhances them to look like full-dose images, which can preserve surgeon and staff longevity without compromising on quality. The platform can also lead to reduced radiation exposure for patients.

MANTIS Percutaneous Screw System (Stryker). The MANTIS — minimal access non-traumatic insertion system — Percutaneous Pedicle Screw System is designed for up to three-level procedures in both degenerative and deformity patients. The system's cannulated screw design is based on Stryker's Xia Pedicle Screw system. Surgeons take a true percutaneous approach to the procedure, and precise rod contouring allows for a more anatomic fit.

Mazor X (Mazor, Medtronic). Mazor X allows surgeons to develop a plan preoperatively using 3D images of the patient's anatomy. The surgical plan includes implant and trajectory placement that surgeons follow during the procedure; however, they have the ability to change course intraoperatively if necessary. Mazor X is Mazor's next-generation robotic spine system, launched last year. Medtronic made a $72 million investment in Mazor X, purchasing several Mazor X systems and assuming exclusive global spine market commercial responsibility for the system. Mazor reported 22 system orders in the third quarter of 2017, 11 by Medtronic.

Mobi-C (Zimmer Biomet). First approved for use in the U.S. in 2004, Mobi-C has become one of the most popular cervical discs on the market. The artificial disc has since achieved FDA clearance for two-level procedures and appeared in peer-reviewed literature examining long-term outcomes. Mobi-C demonstrated a 62.8 percent success rate at 60 months after surgery, compared to 34.1 percent among fusion patients. Mobi-C patients also reported fewer subsequent surgeries, adverse events and lower adjacent level degeneration rates. Return to work was also 21 days quicker for Mobi-C patients than fusion patients.

MySpine (Medacta). MySpine is a patient-matched, 3D-printed technology that tailors minimally invasive spine surgeries to the patient's anatomy for more accurate pedicle screw placement. The technology also allows for customization and reduced radiation requirements as well as shorter hospital stays. Surgeons first take a CT of the patient's spine with specific low-dose CT protocol, and Medacta creates a plastic 3D model based on the images to select the best implant position and size. The company then works with surgeons to create personalized instruments and a surgical plan for patients.

PathFinder NXT Minimally Invasive Pedicle Screw System (Zimmer Biomet). The PathFinder NXT Minimally Invasive Pedicle Screw System is Zimmer Biomet's next-generation minimally invasive spinal fusion system, offering enhanced procedural freedom and streamlined workflow. The system includes proprietary decortication and aspiration instruments to facilitate solid fusions and the PedicleAccess Tool to streamline the pedicle targeting process and workflow. Originally launched in 2011, the PathFinder NXT System addresses multiple pathologies with a less invasive approach.

PediGuard (SpineGuard). The PediGuard probe, a handheld device that detects possible vertebral cortex perforation during pedicle preparation for screw placement, incorporates SpineGuard's DSG Technology. The probe alerts surgeons to breaches by analyzing the electrical conductivity of surrounding tissue in real time. PediGuard probes come in a variety of shapes and sizes to address multiple anatomies and approaches. In June, the company signed an exclusive distribution agreement with XinRong Medical Group to distribute PediGuard in China.

Prolix SI Joint Fusion System (Camber Spine). Camber Spine launched the Prolix SI Fusion System in April 2016 as a minimally invasive approach to treat sacroiliac joint pain. The system's approach is between the posterior superior iliac spine and posterior inferior iliac spine. The surgeon first implants a machined cortical bone spacer between the sacrum and ilium through a cannula. Then, the surgeon treats the space like a discectomy to promote fusion, as opposed to only limiting joint motion, as occurs when only lateral screws are used. The percutaneous procedure consists of implanting a custom machined allograft through direct visualization and a supplemental lateral fixation of the sacroiliac joint.

S4 Element MIS System (Aesculap). The S4 Element MIS system is designed to increase direct surgical site visibility during minimally invasive procedures. The posterior lumbar pedicle screw fixation system uses endoscopic technology to give surgeons a direct view of the surgical site, a comparable view to open procedures. Surgeons can confirm rod delivery, position and length with the system and troubleshoot issues in real time before they develop into complications. S4 also offers a rescue technique and instrumentation to reduce the risk of open conversion.

SiCure Sacroiliac Joint Fusion System (Alevio). The 500th case using Alevio's SiCure Sacroiliac Joint Fusion System was performed in June 2017. This second-generation comprehensive sacroiliac joint fusion system with titanium screws can be implanted with the lateral or posterior approach. SiCure features a patented dual-lead helical thread design for harvesting and repacking the patient's own bone into the screw as it advances, saving time and reducing biologic material costs. Founded in 2015, the company has grown rapidly over the past two years without reporting significant complications with the technology.

SImmetry Sacroiliac Joint Fusion System (Zyga Technology). In April 2017, Zyga enrolled its 100th patient in the EVoluSIon Clinical Study to examine the long-term fusion rate and pain reduction for the SImmetry Sacroiliac Joint Fusion System. Two years after surgery, 83 percent of the patients who had already undergone the minimally invasive procedure as part of the study reported a solid fusion, and 73 percent reported pain reduction. The system consists of several threaded, cannulated implants and associated instrumentation that transfixes the sacrum and ilium, creating the appropriate conditions for bony growth across the SI joint. In June, Zyga received a new U.S. patent representing continued advancement of the SImmetry Sacroiliac Joint Fusion System.

STALIF L (Centinel Spine). The STALIF L is the first FDA-cleared no-profile minimally invasive lateral integrated interbody system to feature a compressive lag screw fixation and Centinel Spine's proprietary anti-backout technology. Built on 30 years of STALIF heritage innovation, the STALIF L is an all-PEEK integrated interbody device that was developed to have multiple lordotic implant configurations that can closely match the patient's normal anatomy. The system is designed to optimize fixation with self-drilling, self-tapping screws and a variety of cage sizes.

Tessys (joimax). Developed more than 15 years ago, Tessys is an endoscopic spine surgery system marketed in 45 countries for use in decompression procedures. Beginning in 2017, the American Medical Association assigned an endoscopic spine surgery code covering endoscopic spinal cord and nerve root decompression, including laminotomy, foraminotomy and discectomy. Tessys uses a lateral transforaminal endoscopic approach for surgeons to resect the herniated disc through the foramen intervertebrale. Surgeons can perform the procedure in the lateral or prone position under general anesthesia or moderated anesthesia care. In August, joimax opened a new Training and Education Center in Irvine, Calif., to instruct U.S. surgeons on endoscopic technique.

Thunderbolt Minimally Invasive Pedicle Screw System (ChoiceSpine). Thunderbolt is a minimally invasive pedicle screw system that provides immobilization and stabilization of spinal segments as an adjunct to fusion in patients with degenerative disc disease, spondylolisthesis, trauma, stenosis, deformity, tumor and pseudoarthrosis. The system includes a user-friendly rod reduction and a dovetail screw set to minimize head splay and cross threading. Thunderbolt received FDA clearance in 2014 and Robert Knetsche, MD, performed the first procedure using the technology in April 2015.

UNiD MIS Rod (Medicrea). The first minimally invasive spine surgery with Medicrea's patient specific UNiD MIS Rod was performed in July at Aurora-based University of Colorado Hospital. The rod is compatible with percutaneous and mini open applications and eliminates the need to modify implants intraoperatively. The company manufactures each rod specifically for the patient prior to surgery. Studies show the patient-specific rod can reduce rod breakage in adult spinal deformity patients.

Viper Prime (DePuy Synthes). Unveiled earlier this year at Eurospine 2017 Congress, DePuy Synthes' Viper Prime is a minimally invasive pedicle screw system designed for fusion procedures. The system reduces instrumentation needed and steps required to insert percutaneous screws by combining the pedicle preparation instruments into one tool. Surgeons only need two instrument trays for Viper Prime procedures, which could make the back table easier to organize and reduce processing costs. A bench study conducted with Viper Prime showed a 33 percent reduction in pedicle screw insertion time compared with other minimally invasive techniques.

Yeung Endoscopic Spine System. Anthony Yeung, MD, developed the Yeung Endoscopic Spine System in partnership with the Richard Wolf Instrument Company to perform selective endoscopic discectomy in patients with herniated, protruded, extruded and degenerative discs. Visualization through the endoscope allows surgeons to selectively remove portions of the herniated nucleus pulposus that contribute to the patient's pain. Dr. Yeung has trained several surgeons in using the FDA-cleared system and helped develop the Dr. Anthony T. and Eileen K. Yeung Endoscopic Spine Center at the University of New Mexico's Rio Rancho-based Sandoval Regional Medical Center, which also trains surgeons in the technique.

Last modified on Tuesday, 07 November 2017 14:48
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