9 Spine Technology and News Highlights August 2018

Corporate News: Stryker Acquires K2M Group Holdings

Stryker Corporation and K2M Group Holdings, Inc., have entered into a definitive merger agreement pursuant to which K2M will become a wholly owned subsidiary of Stryker Corporation. The proposed transaction is expected to close late in the fourth quarter of 2018.

“This acquisition underscores our commitment to the spinal market, which is the largest segment of orthopaedics with significant unmet needs,” said Kevin A. Lobo, Chairman and Chief Executive Officer, Stryker. “We believe K2M will significantly enhance our presence with surgeons, patients, and employees in both the spine and related neurotechnology markets.”

“Joining Stryker will be a very exciting next chapter for our global team and surgeon customers around the world,” said Eric D. Major, Chairman, Chief Executive Officer, and President of K2M. “Stryker’s established leadership in the orthopaedic and neurosurgical market, combined with K2M’s culture of innovation and leadership in complex spine and minimally invasive solutions, represent a powerful opportunity for Stryker to strengthen its leadership in the $10 billion global spine market.”

Sources
Stryker. Press Release: Stryker Announces Definitive Agreement to Acquire K2M. August 30, 2018.

K2M. Press Release: K2M Group Holdings, Inc. Announces Definitive Agreement to be Acquired by Stryker Corporation. August 30, 2018.

Research: CNS Paper of the Year Announced

The Congress of Neurological Surgeons (CNS) awarded Top Paper of the Year to a study by Hay et al titled “Bupivacaine Field Block With Clonidine for Post-operative Pain Control in Posterior Spine Approaches: A Randomized Double-blind Trial,” which was published in the June 2018 issue of Neurosurgery.

This double-blind study of 225 patients at a single center undergoing posterior cervical or lumbar surgery by the same surgeon showed significantly improved and prolonged post-operative pain control with the addition of 150-µg clonidine to local pre-incisional field block with 20-mL bupivacaine compared with using bupivacaine alone in patients undergoing lumbar spine surgeries. The beneficial effect of clonidine plus bupivacaine was more pronounced in patients without pre-operative back pain, and was not found in patients who underwent cervical spine surgery.

View a complete list of the papers of the year by section.

Sources
Congress of Neurological Surgeons. Press Release: The CNS Announces Neurosurgery Publications 2018 Paper of the Year. August 24, 2018.

Abdel Hay J, Kobaiter-Maarrawi S, Tabet P, et al. Bupivacaine field block with clonidine for post-operative pain control in posterior spine approaches: a randomized double-blind trial. Neurosurgery. 2018;82(6):790-798.

New Technology: First Spine Fusion Using Valeo® C+CSC With Lumen Interbody Fusion Device Completed

Amedica Corporation announced the successful completion of the first spine fusion surgery using the Valeo® C+CSC with Lumen Interbody Fusion Device. The device is a composite silicon nitride implant that combines different densities of Amedica's proprietary medical grade silicon nitride ceramic, according to a statement from the company. A solid, outer shell of nanostructured silicon nitride is manufactured around an inner porous layer, called CSC (cancellous structured ceramic).

“The benefits of this new device include the potential for bone in-growth as well as on-growth, while a central lumen gives the surgeon flexibility to add bone graft, if needed,” said Tarek Elalayli, MD, who performed this first procedure. “The device and underlying technology are a step toward spine fusion without the need for bone graft additives; with the advantages of good radiographic visualization, and inherent antibacterial properties of silicon nitride. No other spinal fusion implant combines all these properties,” said Dr. Elalayli, who is an orthopaedic spine surgeon at Advanced Ortho and Spine, Hermitage, TN.

Clinical trial data from the CASCADE study demonstrate that the device achieves spinal fusion without added bone grafts or fillers, at rates similar to those achieved by bone autograft.

Source
Amedica Corporation. Press Release: Amedica Announces Successful Completion of First Valeo® C+CSC with Lumen Interbody Fusion Surgery. August 21, 2018.

Technology Update: Adoption of EOS Imaging Is on the Rise

Methodist Dallas Medical Center installed the EOS system for low-dose, 2D/3D imaging of adult and pediatric patients, making it the 100th system installed in the United States, according to EOS Imaging.

The EOS system produces low-dose, full-body, stereo-radiographic images of patients in functional positions. The bi-planar device uses two perpendicular fan beams of X-rays and proprietary detectors that travel vertically while scanning the patient, producing two simultaneous frontal and lateral images of the whole body or an anatomical segment. A Micro Dose option for pediatric follow-up exams also is available.

“Achieving the 100th EOS installation in the U.S. and 10th in the state of Texas represent great milestones for our company that reflect the adoption of the EOS technology as a standard of care in all orthopaedic points of care, including the large and high growth community hospitals and private practices market,” said Marie Meynadier, CEO of EOS Imaging.

Source
EOS Imaging. Press Release: EOS Imaging Achieves Its 100th Installation in the United States. August 21, 2018.

Technology Update: iFuse Implant System® for SI joint Fusion Now Covered by 23 U.S. Health Insurance Plans

SI-BONE® announced that 23 commercial health plans will exclusively cover the triangular iFuse Implant System® for minimally invasive surgical (MIS) treatment of the sacroiliac (SI) joint. In addition, the French National Healthcare System added the iFuse Implant System to the country’s List of Refundable Products and Services.

The exclusive positive coverage policies in the United States provide access to the iFuse Implant System for over 35 million health plan members covered Blue Cross Blue Shield divisions in 21 states, Select Health, and AmeriHealth. The system is intended for use in sacroiliac joint fusion in patients with conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis, including conditions with symptom onset during pregnancy or in the peripartum period that have persisted for more than 6 months postpartum.

In France, The National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS) concluded that the iFuse Procedure’s observed outcomes—including improvements in quality of life and work status—are sufficient to include iFuse on the list of Products and Services provided for in Article L.165-1 of the Social Security Code.

Sources
SI-BONE. Press Release: SI-BONE, Inc. Announces France’s National Healthcare System Establishes Exclusive Positive Coverage for the Triangular iFuse Implant System for MIS SI Joint Fusion. August 27, 2018.

SI-BONE. Press Release: SI-BONE, Inc. Announces 23 Commercial Health Insurance Plans Now "Exclusively" Cover Triangular iFuse Implant System Based on Published Clinical Evidence. August 7, 2018.

3D-Printing Technology: Implantations of 3D-Printed All-Titanium Interbody Fusion Devices Completed

Initial implantations of three different devices within Centinel Spine’s FLX™ Platform of 3D-printed all-titanium Integrated Interbody and nonintegrated interbody fusion devices were recently completed, according to the company.

FLX devices are 3D-printed, all-titanium implants that combine solid and porous radiolucent sections to reduce mechanical stiffness and improve visibility compared to solid titanium implants, according to Centinel Spine. The devices have a trabecular scaffold to allow for bony in-growth and on-growth throughout the implant. The FDA cleared the FLX Platform of 3D-printed cervical and lumbar interbody devices in May 2018.

“The FLX implant offers an open bone graft window optimizing graft volume and allowing bone growth throughout the trabecular matrix structure,” said Stelios Koutsoumbelis, MD, Chief of Division of Orthopaedic Surgery at South Nassau Communities Hospital, Rockville, NY, who performed the first ACTILIF C FLX Cervical Interbody implantation. “The open configuration also allows for CT visualization postoperatively to assess fusion.”

Source
Centinel Spine. Press Release: Centinel Spine Announces Initial Cases with FLX™ Platform of 3D-Printed All-Titanium Interbodies. August 23, 2018.

3D-Printing Technology: Osseus Fusion Systems Receives FDA Clearance for Five 3D-Printed Interbody Fusion Devices

Osseus Fusion Systems received FDA clearance for its family of five 3D-printed lumbar interbody fusion devices known as Aries. The implants are available for use in lateral, anterior, straight and curved transforaminal lumbar interbody fusion, as well as for oblique lateral interbody fusion procedures using the Kambin’s Triangle approach.

Aries devices are constructed from highly porous titanium material to help optimized bone fusion and biological fixation using 3D-printing technology, making it upwards of 80% porosity, according to Osseus. In addition, the devices have a mesh lattice structure that helps reduce the stiffness of the cage and maximize bone graft packability. The devices are available in a variety of footprints, heights, and lordotic angles.

Source
SPINEMarketGroup. Press Release: FDA Issues Its Largest-Ever Clearance for a Family of 3D-Printed Lumbar Fusion Devices Osseus Fusion Systems Receives FDA 510(k) Clearance for 5 Aries Implants. August 16, 2018.

3D-Printing Technology: Stryker’s Tritanium® Cages Achieve Greater Bony In-Growth Than PEEK Cages

Stryker’s 3D-printed porous Tritanium® cages achieved statistically significant increases in bony in-growth compared to PEEK cages in a preclinical animal study in the July issue of The Spine Journal.

The Tritanium cages showed significantly greater total bone volume within the graft window at both 8 and 16 weeks compared to traditional PEEK cages and plasma-sprayed titanium-coated PEEK cages (P<0.01). Only the Tritanium cages demonstrated significantly decreased range of motion and increased stiffness across all three loading directions (axial rotation, flexion-extension, and lateral bending) between 8 and 16 weeks (P<0.01).

“The results of this study provide an evidence-based approach to decision-making regarding interbody materials for spinal fusion, as there is significant variability in the materials commonly used for interbody cages in spine surgery,” said Sigurd H. Berven, MD, orthopaedic surgeon at the University of California, San Francisco. “The study showed the potential for bone in-growth into and around the Tritanium cages.”

Sources
Stryker. Press Release: Newly Published Data Demonstrate Bone In-Growth Potential of Stryker’s 3D-Printed Tritanium Cage. August 2, 2018.

McGilvray KC, Easley J, Seim HB, et al. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J. 2018;18(7):1250-1260.

3D-Printing Technology: 3D-Printed Scaffolds Imbedded With Stem Cells May Help Spinal Cord Injuries

Researchers have used 3D-printing technology to print stem cell-infused scaffolds that may have the potential to alleviate nerve damage in patients with spinal cord injury, as reported in Advanced Functional Materials.

Neuronal stem cells derived from adult human cells were 3D-printed on a 3D-printed silicone guide. The guide could be implanted into the injured area of the spinal cord where it would serve as a type of bridge between living nerve cells above and below the area of injury, according to the researchers.

“This is the first time anyone has been able to directly 3D-print neuronal stem cells derived from adult human cells on a 3D-printed guide and have the cells differentiate into active nerve cells in the lab,” said coauthor Michael McAlpine, PhD, Benjamin Mayhugh Associate Professor of Mechanical Engineering at the University of Minnesota College of Science and Engineering.

“3D-printing such delicate cells was very difficult,” Dr. McAlpine said. “The hard part is keeping the cells happy and alive. We tested several different recipes in the printing process. The fact that we were able to keep about 75% of the cells alive during the 3D-printing process and then have them turn into healthy neurons is pretty amazing.”

Sources
University of Minnesota. Press Release: New 3D-printed device could help treat spinal cord injuries. August 9, 2018.

Joung D, Truong V, Neitzke CC, et al. 3D-printed stem‐cell derived neural progenitors generate spinal cord scaffolds. Advanced Functional Materials. 2018;doi.org/10.1002/adfm.201801850.

Updated on: 09/06/18
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