SI-BONE, Inc. Announces SelectHealth of Utah to Cover Minimally Invasive Sacroiliac Joint Fusion Exclusively Using the iFuse Implant System® as the Only Proven Technology

Posted On October 27, 2016 By OrthoSpineNews In Financial /

SAN JOSE, Calif., Oct. 27, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System (“iFuse”), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that SelectHealth, a health plan division of Intermountain Healthcare, a Utah-based not-for-profit healthcare system, will provide coverage specific for iFuse and exclusive of all other MIS SI joint fusion systems, beginning November 1, 2016. SelectHealth joins Geisinger Health System as the second commercial health plan in the United States to provide exclusive coverage for iFuse and a growing list of commercial payors to provide positive coverage policies for MIS SI joint fusion, including Blue Cross Blue Shield (BCBS) of Michigan, Priority Health of Michigan and BCBS of Nebraska.

Based on an extensive review of the published medical literature, the SelectHealth Medical Technology Assessment Committee determined that coverage of minimally invasive (MIS) SI joint fusion specific to iFuse was appropriate as the literature related to other MIS SI joint fusion systems was inadequate to determine safety and effectiveness. Use of all other technologies is considered experimental/investigational or unproven and therefore not covered.

The coverage decision was based on two systematic reviews of the literature and 27 primary studies that met inclusion criteria. The primary literature included outcomes from 7,589 patients who underwent SIJ fusion. The two systematic reviews included 34 studies, 18 of which reported on outcomes from MIS SIJ fusion and 16 that compared open to MIS fusion procedures. All of the 27 primary studies used only iFuse, with no studies identified for any other MIS SI joint fusion systems. iFuse is the only SI joint fusion device with an FDA cleared indication citing clinical studies that demonstrate improvements in pain, patient function and quality of life. Peer-reviewed published data supporting the use of iFuse includes two randomized controlled trials (RCTs) of iFuse vs non-operative care (INSITE and iMIA), long term results from a prospective single-arm multi center trial (SIFI) as well as data from over 40 additional publications.

“This latest exclusive positive coverage policy for iFuse by SelectHealth brings the exclusive coverage total to almost 4 million lives throughout Utah and parts of Pennsylvania and New Jersey and further demonstrates the importance of high quality published clinical evidence, establishing iFuse as the only proven option for MIS SI joint fusion,” said Jeffrey Dunn, President and CEO of SI-BONE. “We are committed to continuing to work with other payors and health plans across the US to ensure all patients who may benefit from this procedure have access to iFuse.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back complaints related to certain SI joint disorders. The company develops, manufactures and markets minimally invasive products for the SI joint. SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010. The iFuse Implant System is a minimally invasive surgical system that uses titanium implants with a porous surface to create an interference fit designed to help decrease joint motion and allow for bone ongrowth and ingrowth, supporting long-term fusion.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

Spineology Announces Palisade™ Pedicular Fixation System Milestone

Posted On October 27, 2016 By OrthoSpineNews In Spine /

October 26, 2016

MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving surgery™, is excited to announce the completion of 100 cases using the new Palisade Pedicular Fixation System. Palisade is one of several recent additions to Spineology’s Anatomy-Conserving Technology (ACT™) product platform.

“Reception of the Palisade system has been outstanding and we expect it to be a significant contributor to the growth of the company,” said John Booth, CEO of Spineology. “The Palisade implants and instrumentation follow Spineology’s anatomy-conserving design philosophy of preserving patient anatomy and limiting operating room time.”

The Palisade System includes articulating rod passing capability and low-profile implant components to maximize conservation of anatomy, with the goal of speeding postoperative recovery for the patient. The Palisade screw utilizes a quick-starting thread design, integrated reduction threads, and break-off extensions to improve surgical efficiency and limit intraoperative imaging requirements.

Spineology will be showcasing Palisade at the National Association of Spine Surgeons (NASS) Meeting taking place October 26-29 in Boston, MA (Booth #403).

About Spineology Inc.

Spineology Inc. provides innovative, anatomy conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

Zimmer Biomet Acquires RespondWell® Telerehabilitation Platform for Zimmer Biomet Signature Solutions™

Posted On October 27, 2016 By OrthoSpineNews In Financial /

(WARSAW, IN) October 27, 2016—Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the acquisition of RespondWell^®, an award-winning telerehabilitation technology designed to provide personalized, clinician-supervised post-surgical physical therapy in the comfort of a patient’s home. The acquisition strengthens the Company’s recently announced Zimmer Biomet Signature Solutions™ commercial offering by integrating a comprehensive, at-home telerehabilitation capability designed to enhance patient compliance with physical therapy and improve the quality of recovery.

“The new value-based reimbursement environment compels hospitals and providers to assume responsibility for patient outcomes well after discharge and through the critical rehabilitation period,” said David Nolan, Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle and Office Based Technologies, Zimmer Biomet. “Integrating an innovative and comprehensive telerehabilitation program into our Zimmer Biomet Signature Solutions offering addresses the emerging need for healthcare providers to oversee and optimize post-surgical recovery outcomes in order to maximize value across the entire episode of care.”

“I believe RespondWell’s innovative telerehabilitation platform will help our clinical care team enhance the quality and outcomes of post-op patient care by providing an interactive and motivating physical therapy experience that encourages patient engagement and compliance to physical therapy in a convenient environment, the patient’s home,” said Ronald A. Navarro, M.D., Regional Coordinating Chief of Orthopedic Surgery, Kaiser Permanente.

Zimmer Biomet Signature Solutions is a strategically-curated suite of technologies and services designed to help hospitals and providers streamline delivery of care and succeed in today’s value-based reimbursement environment. The Zimmer Biomet Signature Solutions remote rehabilitation platform, known as Therapy@Home, features a personalized rehabilitation plan designed by a patient’s clinical care team, video-gaming-style exercise system with on-screen digital instructors to coach and encourage patients, and built-in reward features earned through increased patient participation and consistency. The system also allows the patient’s clinical care team to remotely monitor patient progress and activity and digitally communicate with the patient, potentially reducing the costs associated with follow-up visits and clinic-based rehabilitation programs. Zimmer Biomet is currently launching research partnerships for the Zimmer Biomet Signature Solutions suite at selected academic research institutions in the U.S., with a broader commercial release scheduled for 2017.

“Telerehabilitation represents the future of optimal and efficient post-surgical patient care, and we are excited to integrate our remote rehabilitation platform into the Zimmer Biomet Signature Solutions suite,” said Ted Spooner, Co-founder and CEO of RespondWell.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

Media

Investors

Monica Kendrick

Robert J. Marshall Jr.

574-372-4989

574-371-8042

monica.kendrick@zimmerbiomet.com robert.marshall@zimmerbiomet.com

Barbara Goslee

574-371-9449

barb.goslee@zimmerbiomet.com

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Tyber Medical Launches TyPEEK® Lateral Implant System

Posted On October 27, 2016 By OrthoSpineNews In Spine /

BETHLEHEM, Pa., Oct. 26, 2016 /PRNewswire/ — Tyber Medical, a privately held company focused on developing innovative medical devices for private label opportunities and advancing the science of bioengineered surfaces, announces the full commercial launch of their lateral access system, 2^nd Generation lateral PEEK/titanium composite interbody and lateral plating system.

Tyber Medical is excited to announce the launch of a comprehensive and cohesive lateral system. The Tyber Medical lateral access retractor, which is critical to a successful procedure, utilizes a popular 3 blade design and capitalizes on current levels of surgeon training and expertise. The approach and disc preparatory instruments are heavy on surgeon input, were designed for multiple levels including the difficult to access L4/L5, and have been tested against the best in the field. The TyPEEK®, titanium plasma sprayed PEEK, composite interbody fusion devices provide access to the newest and fastest growing interbody segment in fusion technology. Completing the system is a lateral plating system that provides three points of fixation in each vertebral body with only two screws, eliminating some instrumentation required by other systems on the market, minimizing surgical steps, and freeing up real estate normally required by four screw plates.

“Our team has done a tremendous job to deliver a system targeting two of the hottest growth areas in the spine market; exotic material interbodies and the MIS lateral procedure,” commented Jeff Tyber, CEO of Tyber Medical. He added “The Tyber Medical private label model allows our customers to rapidly access this market and growth without spending resources on development and, at the same time, eliminating timeline risk.”

According to multiple market research sources, the global market for minimally invasive surgery is forecast to grow faster than any other segment over the next 3 – 5 years. Visit the Tyber Medical Booth #507 at NASS where the company will showcase the complete lateral system along with a number of other spine products available for private labeling.

About Tyber Medical:

Tyber Medical, LLC, Morristown, New Jersey, a rapid commercialization device company, is creating new pathways to regulatory approved bioengineered implants and instruments for orthopedic companies, large distributors, and hospital organizations. Tyber Medical designs and develops full class II orthopedic systems; verifies and validates those systems using a QSR and ISO 13485 certified quality system; and pursues and maintains both US (FDA 510k) and OUS (CE Mark) regulatory approvals. Current products include the opening osteotomy system, headless and headed compression screws, snap-off screws, cervical plating system, lateral retractor system and spinal interbody spacers featuring both standard sterile and non-sterile PEEK and TyPEEK^®, a proprietary titanium plasma sprayed PEEK. The company is also developing BioTy™, a nanotopography surface modification which limits the adherence of bacteria to implants. For more information, please visit www.tybermedical.com.

The TyWedge™ System and Spinal Interbody Spacers are made with PEEK-OPTIMA^® from Invibio^® Biomaterial Solutions.

Contact:
Steve Zeiger
83 South Commerce Way, Suite 310
Bethlehem PA 18017
(866) 761-0933
szeiger@tybermed.com

SOURCE Tyber Medical

Mazor Robotics Commercially Launches Mazor X at the North American Spine Society (NASS) Annual Meeting

Posted On October 27, 2016 By OrthoSpineNews In Robotics /

October 26, 2016

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE:MZOR; NASDAQGM:MZOR), a pioneer and a leader in the field of surgical guidance systems, launched Mazor X, a transformative platform for spine surgeries at the North American Spine Society (NASS) annual meeting being held in Boston, Massachusetts from October 26 – 29. The Mazor X system represents a new surgical assurance platform for predictable surgery and patient benefit and it will be displayed at the Mazor and Medtronic booths, #931 and #1015, respectively.

“The Mazor X system is the culmination of a multi-year development effort by our team of robotic, algorithm and imaging experts, incorporating market feedback gathered from thousands of clinical cases performed with the Mazor core technology. It exemplifies our vision of healing through innovation and our ongoing dedication to patients by expanding guidance capabilities in the spine operating room,” commented Ori Hadomi, Chief Executive Officer. “Mazor X is a transformative guidance system with advanced features and sophisticated integrative abilities. We believe it can change the way spine surgeries are performed.”

The commercial release of the Mazor X is a significant milestone for Mazor as well as for the Company’s strategic partnership with Medtronic that was announced in May 2016. Since signing the agreement in May, Mazor and Medtronic have invested in co-marketing, promotion, and training efforts towards commercialization of the Mazor X. The two companies, between them, now have hundreds of highly experienced capital and clinical specialists who are trained on Mazor X, who will be responsible for raising the awareness of, selling and supporting the Mazor X system. In response to the pre-launch activity by Mazor and Medtronic, dozens of surgeons have attended Mazor’s labs and been introduced to the Mazor X.

In July 2016, Mazor first unveiled the Mazor X. “The pre-launch interest has been exceptional and we are excited to publicly introduce the Mazor X at the prestigious NASS annual meeting. We expect that today’s announced commercial availability will further increase the momentum we are experiencing and drive the future sales of Mazor’s portfolio of products – the advanced Mazor X platform and the clinical workhorse Renaissance system,” commented Mr. Hadomi.

Due to this rising interest, the Company established an exchange (post-sale) program for existing U.S. Renaissance users to expand to the Mazor X system. Since the July unveiling, the Company has received three pre-launch orders prior to today’s commercial launch, with scheduled deliveries by the end of the 2017 first quarter. Additionally, the Company also received a purchase order from Medtronic for 15 Mazor X systems.

About Mazor Robotics

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding future sales of Mazor’s products, the interest in and benefits of Mazor X, scheduled deliveries of Mazor X, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 2, 2016 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

Contacts

EVC Group
Michael Polyviou, 732-232-6914
mpolyviou@evcgroup.com
or
Investors
Doug Sherk, 415-652-9100
dsherk@evcgroup.com

DePuy Synthes Companies Launches Portable Spine Imaging System to Help Expand Access to Advanced Visualization and Improve Patient Outcomes

Posted On October 27, 2016 By OrthoSpineNews In Spine /

BOSTON – OCTOBER 26, 2016 – Image-guided surgery systems that provide real-time guidance for minimally invasive spine surgery can help improve patient outcomes, but these systems are costly for many hospitals. Surgeons may rely on checking implant placement with multiple static X-ray images that do not provide the real-time guidance of navigation. A new visualization option from DePuy Synthes Spine*, the KICK^® System with FluoroExpress Software Module, being showcased here at the North American Society Spine Meeting (NASS), aims to improve access to affordable advanced imaging technology so that surgeons can confirm proper placement of spinal implants while saving time in the operating room.

Research has shown that only 11 percent of spine surgeons in North America and Europe use advanced imaging technologies, even though image-guided spine surgery helps achieve accurate screw insertion and reduces the likelihood of revision surgery to adjust screw placement.[1][2] DePuy Synthes Spine, Part of the Johnson & Johnson Family of Companies, has partnered with navigation leader Brainlab to expand access to advanced visualization through the KICK System. This image-guided surgery technology enables real-time intraoperative viewing of instrumentation and implants relative to patient anatomy to permit proper pedicle screw placement. Using a small, portable infrared camera with a computer and monitor, the system moves easily between operating rooms and works together with existing X-ray equipment to support surgical workflow. The monitor displays up to four different X-ray images at one time to make X-ray equipment repositioning to capture different views unnecessary—ultimately reducing radiation exposure and surgery time.[3]

The KICK System is compatible with the VIPER^® System and the EXPEDIUM^® Spine System of implants, enhancing visualization during minimally invasive and open procedures to treat a broad range of spinal disorders.

“Building on our commitment to enabling technologies, the KICK System enhances less invasive surgery for the clinician who may not have access to expensive 3D imaging systems, but recognizes the need for advanced imaging to support a successful fusion procedure and help improve patient outcomes,” said Dan Wildman, Platform Leader, DePuy Synthes Spine. “Through solutions such as the KICK System, we are improving access to care and creating and delivering clinical and economic value to healthcare systems worldwide.”

In recognition of the need to broaden access to image-guided surgery in spine, the AO Foundation’s technical commission (AOTK) approved the use of the KICK System in AO education courses. The KICK System is the first advanced visualization technology in spine to be approved by the AO Foundation, providing an opportunity for more surgeons around the world to be trained on image-guided surgery. DePuy Synthes and the AO Foundation have a longstanding collaboration, which helps deliver world-class education and supports innovation to improve patient outcomes and increase efficiency of care.
About DePuy Synthes Companies

DePuy Synthes Companies, Part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive orthopaedic solutions in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*A division of DePuy Orthopaedics, Inc.

The third-party trademarks used herein are trademarks of their respective owners.

KICK is a registered trademark of Brainlab AG in Germany and/or the U.S.

[1] Lam, K, et al. Worldwide Survey on the Use of Navigation in Spine Surgery. World Neurosurgery. 79(1). March 2012.

[2] Tormenti, M.J., et al., Intraoperative computed tomography image-guided navigation for posterior thoracolumbar spinal instrumentation in spinal deformity surgery. Neurosurgical focus, 2010. 28(3): p. E11.

[3] DSUS/SPN/0516/1287

Life Spine® Achieves 32% Sales Growth and Announces Industry’s Largest Post-Packing Capabilities for Lateral Fusion

Posted On October 26, 2016 By OrthoSpineNews In Financial, Spine /

October 26, 2016

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today achievement of another astonishing growth milestone, with a sales growth rate of 32% in the third quarter of 2016, as compared to the same quarter in 2015.

Life Spine also announced today industry-leading post-packing capabilities with its e-LIF^™ Expandable Lateral Interbody Fusion procedure, which includes the CENTRIC^®Expandable Retractor System, the LONGBOW^™ Expandable Lateral Interbody System, the SENTRY^™ Lateral Plate System and the newly launched Graft Delivery Device. LONGBOW is the first lateral A/P expanding interbody, providing nearly double its width during in-situ expansion. LONGBOW reduces muscle retraction and potential nerve damage, and when LONGBOW is combined with the Graft Delivery Device, which seamlessly integrates with the LONGBOW in-situ, post-pack graft volumes of over 11cc can be delivered.

“We are excited to add another great product to our existing MIS thoracolumbar portfolio. The addition of the Graft Delivery Device has been very well received by surgeons, and the e-LIF procedure has the potential for increased fusion rates and improved patient outcomes,” said Mariusz Knap, Vice President of Marketing at Life Spine.

Life Spine will be displaying its entire product portfolio at the 31^st North American Spine Society (NASS) Annual Meeting, taking place this week in Boston, and will be located at Booth #1031.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit http://www.lifespine.com.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Spinal Elements® and Mighty Oak Medical Announce Marketing Collaboration for FIREFLY® Patient-Matched, 3D Printed Spine Surgery Solutions

Posted On October 26, 2016 By OrthoSpineNews In Spine /

October 26, 2016

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, announced that they will be working with Mighty Oak Medical to market the FIREFLY® surgical guidance system.

The FIREFLY® system consists of bone models and guides precisely matched to the patient’s anatomy through concierge pre-surgical planning and proprietary computer-designed guidance solutions. Using data from the patient’s computed topography (CT) scan, Mighty Oak Medical is able to make highly accurate patient-specific pedicle screw guides to be used intraoperatively. The guides and bone models are created using the latest 3D printing technologies.

Navigation has become increasingly more popular with surgeons as a way to achieve improved screw placement accuracy. Image-guided and robotic-assisted systems are available at some facilities, but can be extremely expensive, requiring capital equipment installations at the facility. This makes the technology less accessible to smaller centers and can require surgeons to wait on equipment availability.

The FIREFLY® Pedicle Screw Navigation Guide system has no capital equipment requirements, and intraoperative imaging (and thus radiation exposure) may be reduced due to the accuracy of the patient-matched guides. This makes FIREFLY® an attractive alternative to control costs and improve safety for all stakeholders.

Heidi Frey, President of Mighty Oak Medical, had this to say: “We are excited to partner with Spinal Elements on this technology. We feel confident that once surgeons experience the ease of use and accessibility of the FIREFLY® system, they will gravitate towards predetermined screw sizes and trajectories, implemented with 3D printed patient-specific guides, as a preferred course of treatment for their patients. Spinal Elements, being a technology leader, is a natural partner choice for us to market this technology.”

Spinal Elements will be exhibiting (Exhibit 1341) October 26^th through the 28^th at the North American Spine Society meeting in Boston. The FIREFLY® technology will be on display within the Spinal Elements exhibit.

About Spinal Elements

Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefiting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit www.spinalelements.com.

Contacts

for Spinal Elements
Laura Charlton (formerly Johnson)
laurajohnsonpr@yahoo.com ▪ 760.450.7749

Medacta Announces First Surgeries With MySpine Low Profile Guide Following FDA Clearance

Posted On October 26, 2016 By OrthoSpineNews In Spine /

October 26, 2016

CHICAGO–(BUSINESS WIRE)–Medacta International, the privately held, family-owned global leader in the design of innovative joint replacement and spine surgery products, announced today the successful completion of the first U.S. surgeries by Dr. Raymond Golish in Jupiter, Fla. and Dr. Arnold Vardiman in San Antonio, Texas utilizing its innovative and proprietary 3D-printed MySpine Low Profile Guide, part of the company’s award-winning MySpine Patient Matched Technology, following its recent FDA clearance. Medacta’s MySpine products will be on display starting today at the North American Spine Society (NASS) Annual Meeting (Booth #1651), being held October 26-29, 2016 in Boston.

Demonstrating Medacta’s longstanding commitment to surgical education and training, Dr. Golish and Dr. Vardiman were introduced to the technology at one of Medacta’s industry-leading education forums focused on MySpine technology. “My work requires me to stay on the leading edge of new technologies and techniques for minimally invasive surgery,” Dr. Golish stated. “The MySpine Low Profile Guide sets a new standard for spine surgery and is well-positioned for safe, reproducible results in less invasive instrumentation of the lumbar and thoracic spine.”

Dr. Golish continued: “With the simple, yet thorough preoperative planning and 3D-printed spine guides, I was able to decrease overall operating room time and have better confidence in visualizing the screw trajectory while reducing the need for CT radiation. The patient from my first case is doing very well.”

Dr. Golish and Dr. Vardiman also utilized Medacta’s M.U.S.T. Pedicle Screw System, which requires only one set of dedicated instruments compatible with percutaneous, mini-open, and open procedures.

Orthopedics This Week named Medacta’s MySpine Standard Profile a Best New Technology for Spine Care when it was first released in 2014. The new Low Profile Guide builds on that success to better help spine surgeons identify pedicle entry points, screw trajectories, and implant specifications to potentially increase accuracy and outcomes. The recently launched MySpine Low Profile Guide lowers exposure for an even less invasive approach that is well-suited for degenerative and deformity surgeries of the thoracic and lumbar regions. The MySpine Low Profile Guide received 501(k) clearance from the U.S. Food and Drug Administration in August 2016.

“Our MySpine Low Profile Guide marks another step forward in Medacta’s continued focus on procedural innovation in spine surgery and adds to Medacta’s already impressive and extensive spine portfolio,” said Francesco Siccardi, Executive Vice President of Medacta International. “The Medacta difference stems from the strong emphasis we place on surgeon training and education, as well as better procedural focus to simplify the complex nature of spine procedures.”

In addition to showcasing its MySpine technologies at NASS 2016, Medacta will hold an educational workshop, the “M.O.R.E. Spine Workshop: Discover Medacta Spine Innovations,” in the conference’s Yellow Lab on Thursday, October 27 at 5 p.m. For more information on Medacta’s spine portfolio, visit https://www.medacta.com/en/usa/medical-professionals/products/spine/spine or contact cbaldwin@medacta.us.com.

About Medacta

Medacta^® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS^®system and total knee replacement with MyKnee^® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

Synaptive Medical to Showcase BrightMatter™ Technology at North American Spine Society in Boston

Posted On October 26, 2016 By OrthoSpineNews In Robotics /

October 26, 2016

TORONTO–(BUSINESS WIRE)–Synaptive Medical is showcasing their BrightMatter™ technology at the upcoming North American Spine Society (NASS) annual meeting in Boston, Massachusetts, which starts today and runs through Oct. 29.

This is the first time Synaptive has attended NASS and will demonstrate their robotics and visualization technology at Booth # 1366. BrightMatter supports a multidisciplinary approach to patient care through informatics, advanced imaging, and robotics that bring state-of-the-art visualization to the operating room.

Dr. Tom Doers, an Orthopedic Spine Surgeon at Aurora St. Luke’s Healthcare in Milwaukee, Wisconsin, will present his clinical experiences with Synaptive’s robotic technology at a special NASS session on advancements in innovation for spine surgery. His session will explore how using the robotic arm for visualization has impacted his patients and increased communication with his staff. He will also speak to the impact of Synaptive’s technology on him physically, especially on days where he may perform as many as six spine procedures.

As health care shifts to delivery models that are increasingly focused on increased efficiency and higher quality of care, Synaptive’s BrightMatter technology is addressing this new paradigm with solutions for transformative insights from diagnosis through post-operative care, and beyond.

One of the challenges in spine surgery is direct visualization of neural structures and soft tissues. Surgeons will often use surgical microscopes or loupes with illumination mounted to their head, a solution to visualization that was developed in the 1800s. As a result, the operating team often cannot see what the surgeon can see and surgeons often perform surgery in positions that can cause fatigue, pain and unfavourable health outcomes.

BrightMatter addresses the complexities of the operating room setup and transforms the surgical workflow. With a camera mounted on a robotic arm to automatically follows the surgeon’s instruments, a wider customizable field of view is projected onto a large monitor and viewable by the entire operating team. Surgeons spend less time manipulating cumbersome optics and are able to work in a comfortable upright position while actively communicating with their staff during the procedure to ensure the best patient outcome.

“Collaborations with surgeons like Tom Doers are rooted in Synaptive’s culture of pursing integrated connections across the process of care,” said Cameron Piron, president and co-founder of Synaptive Medical. “Understanding the unique challenges facing spine surgeons fuels our product development and helps us to design integrated solutions. We’re excited to be attending NASS for the first time and looking forward to developing this key market.”

About Synaptive Medical | Synaptive Medical Inc., a Toronto-based medical device company, has a talented team of scientists, engineers and locally-based customer care specialists specifically committed to developing and supporting surgical technologies and therapies. Their BrightMatter™ Solutions provide advanced tools and information that allow surgeons to focus on patient outcomes. From advanced visualization and guidance to their first hands-free surgical scope, Synaptive Medical collaborates with surgeons, hospitals and industry partners to evolve the standard of care for surgical intervention.

Contacts

Synaptive Medical
Sherrie Van Oss, 404-290-9664
sherrie.vanoss@synaptivemedical.com

Month: October 2016

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