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4 New Technologies in Spine, Joint Replacement, Trauma, Sports Medicine

Small and mid-sized orthopedic companies bolstered their portfolios at year-end with products to help grow revenue in the coming year. Launches include an enabling technology for spine, a new option to support the direct anterior approach in hip replacement, a new sterile-packed solution for foot surgery and an artificial meniscus.

Spine

ATEC Spine commenced full launch of the SafeOp Neural InformatiX System™ for spinal procedures, the neuromonitoring component of the company’s Alpha InformatiX platform. Leadership expects SafeOp to be a key factor in selling entire surgical approaches with an associated increase of products sold per surgery.

SafeOp Neural InformatiX employs electromyography (EMG) and somatosensory evoked potentials (SSEP) to provide surgeons with actionable information about the location and health of nerves at potential risk during a procedure. The system connects wirelessly and occupies a small footprint in the O.R.

For lateral lumbar procedures, EMG nerve detection informs the direction and proximity of relevant neural anatomy during the surgical approach, and SSEP delivers the ability to reproducibly monitor nerve health. That capability can help mitigate femoral nerve complications, often a challenge to the adoption of lateral surgery.

SafeOp is designed to improve the safety and reproducibility of posterior fixation, which encompasses 90% of all spine fusions. When used with the Invictus™ Posterior Fixation approach, SafeOp’s EMG technology delivers nerve detection during screw placement, reducing the risk of pedicle breach.

Joint Replacement 

        nextstep blade  
        The Blade  

NextStep Arthropedix launched The Blade™, a femoral stem component for the iNSitu™ Total Hip system. The bi-planar taper geometry builds on 30 years of proven data for this design philosophy, and joins other iNSitu components such as femoral heads (including a BIOLOX®delta ceramic head made by CeramTec), acetabular shells, acetabular liners, acetabular bone screws, etc.

The Blade is designed for the Direct Anterior Approach and features a reduced lateral shoulder and a lateral sweep at the distal tip in a length that is 5mm shorter than its competition. It is presented with a two-tray instrument system.

The Blade dual taper stem is offered in a size range from 3 to 24. Sizes 3 and 4 represent the smallest dual taper stem on the market.

Trauma 

Nextremity Solutions completed initial cases during limited commercial launch of a single-use, sterile version of InCore® Lapidus for first tarsometatarsal fusion. The system allows for tri-planar correction through the use of a Targeting Guide that aids and stabilizes angular/rotational correction in the transverse, sagittal and frontal planes.

This sterile version of the reusable system was developed for health systems that seek to eliminate the need to process a reusable set and to support the ability to use brand new instrumentation with every procedure. Company CCO, Ryan Schlotterback, has said, “We’ve found that hospitals, as well as ambulatory surgical centers, find an advantage with single-use, sterile packed kits as it saves them from reprocessing activities as well as having to inventory large amounts of reusable kits. This helps when getting product approval at the value analysis committee level.”


Sports Medicine 

Two patients in Israel have undergone knee surgery with Active Implants’ NUsurface® Meniscus Implant (pictured above), the first artificial meniscus to be marketed in the Middle East. Previously, the device was only available in Israel for clinical trials.

        ActiveImplantsImplant horizontal  
        NUsurface Meniscus
Implant
 

Studies have shown that many meniscectomy patients continue to experience pain that affects quality of life and can lead to knee replacement. Transplant tissue is scarce, and waiting lists exist in many countries. NUsurface offers an alternative.

The polymer device, inserted in the knee joint through a small incision, is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the joint. It does not require fixation to bone or soft tissues.

In the U.S., NUsurface was granted a Breakthrough Device Designation from FDA. The program expedites the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions. (The device is not yet FDA-cleared.)

“Filling the gap in treatment options between minimally invasive meniscus repair and total knee replacement is a large unmet need in the orthopedic market,” said Ted Davis, President and CEO of Active Implants. “The NUsurface Implant was invented and developed in our R&D center in Israel, so for us it is very exciting to finally bring the device to people in Israel.”



Julie A. Vetalice
is ORTHOWORLD’s Editorial Assistant.

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