EIT Cellular Titanium® Scaffold Provides Better Primary Stability, Less Subsidence and Similar Fusion Results to PEEK in Combination with Autograft

Posted On May 3, 2018 By OrthoSpineNews In Spine, Top Stories /

(PRWEB) MAY 03, 2018

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that the results of the EFFECT trial have been presented at the SSA 2018 meeting in Adelaide.

The EFFECT Trial is a prospective controlled trial, evaluating the clinical and quantitative radiological results of 50 patients, who received a single level stand-alone EIT Cervical Implant with no addition of biologics and no use of a plate or screw-fixation. The 3, 6 month and 1-year results have been compared to historical data of a cohort of patients with single level stand-alone PEEK cages with autograft (acknowledged as the ‘golden standard’) that evaluated the exact same outcome parameters.

All clinical parameters (NDI, VAS neck, VAS arm, and EQ5D) improved significantly at 3 months follow up, with a slight improvement further over time. The results did not differ from the clinical outcome in the PEEK-autograft cohort.

That the EIT cervical implant warrants an excellent primary stability without additional fixation could be observed from the significant decline of the mean Range of Motion (RoM) from 8,7° pre-operatively to 2,5° after 3 months in the EIT group, whereas this remained 3,4° in the PEEK-autograft group. The decline of the RoM measured with validated software on functional X-rays over time was chosen as an objective criteria for the quality and speed of fusion. In calculating the fusion rate (less than 2° angular motion), the EIT group outperformed the PEEK-autograft group at every time frame.

“This study has objectified our experience with the international version of the EIT Cervical Implant, that has no graft hole window. Without the need for adding biomaterials or supplemental fixation we get favorable clinical and fusion results, which is also very interesting from a cost perspective”, said Jasper Wolfs, M.D., Neurosurgeon at the Medical Center Haaglanden, The Hague, Netherlands.

Although the EIT implant is made of titanium, the 3D-printed scaffold with 80% porosity, warrants a more ‘elastic’ biomechanical behavior. This was also reflected in the subsidence rate, which was lower for the EIT Cervical Implant compared to the PEEK cage.

“Frustration at the clinical shortcomings of existing cage designs and materials on the
market provided the impetus for the creation of EIT Cellular Titanium®”, says Nancy Lamerigts, M.D., Ph.D., VP research and marketing of EIT: “Previous market solutions had issues in either one or more of the areas of fusion, biocompatibility, subsidence, migration and imaging distortion. The results of the EFFECT trial objectify that we are able to tackle all areas for the better and significantly add value to the patients, surgeons and payers”.

About EIT

EIT is the first medical device manufacturer to exclusively focus on spinal implants, that are designed according to latest science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014. Implants and Instruments are made in Germany.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of EIT Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 15.000 EIT cases have been performed in over 15 markets globally. EIT received various FDA approvals and began introducing products in the US in Q4 of 2017.

Medtronic Announces Advanced SynergyTLIF(SM) Workflow for Minimally Invasive Lumbar Spine Surgery

Posted On May 2, 2018 By OrthoSpineNews In Spine, Top Stories /

DUBLIN and NEW ORLEANS – May 2, 2018 – Medtronic plc (NYSE: MDT) today announced the advanced SynergyTLIF^SM workflow – a procedural solution for spine surgery that combines innovative technologies to create a completely navigated minimally invasive procedure that allows fewer intra-operative surgical steps. The announcement was made during the American Association of Neurological Surgeons (AANS) annual meeting in New Orleans, La.

The advanced SynergyTLIF Workflow combines the O-arm(TM) System imaging and StealthStation(TM) imaging guidance for navigated:

Minimally invasive access
Screw preparation via navigated Stealth-Midas(TM) Drilling System
Interbody disc preparation instruments
Interbody placement of the Elevate(TM) Spinal System expandable interbody device
Screw placement of the CD Horizon(TM) Solera(TM) Voyager(TM) 4.75 and 5.5 ATS(TM) Screws

“The advanced SynergyTLIF workflow allows me to see every step of the patient’s minimally invasive procedure through real-time 3D imaging,” said Dr. Jean-Pierre Mobasser, neurosurgeon at Goodman Campbell Brain & Spine/Indiana University, Department of Neurosurgery in Indianapolis, Ind. “The ATS(TM) Screw Technology provides procedural efficiency by eliminating guidewires and reducing the number of surgical steps thanks to a uniquely designed awl-tipped screw that can penetrate cortical bone without the need for a separate drill or tap.”

The new CD Horizon Solera Voyager 5.5 System has percutaneous and mini-open rod insertion options for treating both degenerative and adult deformity conditions. The system features both cannulated and non-cannulated screw options. The non-cannulated ATS screw reduces the number of screw placement steps from nine to three (versus traditional pedicle screw placement). The advanced SynergyTLIF workflow incorporates Elevate Spinal System’s expandable cage technology, which allows lordotic expansion to be tailored to the patient’s unique anatomy and sagittal alignment needs.

“This new workflow is another example of how our portfolio breadth enables us to transform spine outcomes for patients, surgeons, and hospitals,” said Doug King, senior vice president and president of Medtronic’s Spine division, which is part of the Restorative Therapies Group. “Patients are top of mind when we develop our state-of-the-art minimally invasive technologies, but creating operating room efficiencies is also at the forefront of our innovation.”

The Elevate Spinal System incorporates the technology of Gary K. Michelson, MD.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts:
Victor Rocha
Public Relations
+1-901-399-2401

Ryan Weispfennig
Investor Relations
+1-763-505-4626

ChoiceSpine™ Launches Tiger Shark,TM a Next-Generation Porous Interbody System at AANS 2018

Posted On May 1, 2018 By OrthoSpineNews In Spine, Top Stories /

KNOXVILLE, TENN. (PRWEB) MAY 01, 2018

ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, announced today at the American Association of Neurological Surgeons’ Annual Scientific Meeting the commercial launch of Tiger Shark, a 3D manufactured, titanium alloy interbody device created with a proprietary, organic, porous structure called BioBond.

With the aide of the BioBond porous structure, Tiger Shark was designed with a generous graft window, large boney ingrowth surface area, and a variety of anatomical footprints. The Tiger Shark interbody has a smooth, bulleted-shape, leading edge for fast insertion to accommodate posterior, transforaminal, and lateral surgical approaches.

“We are very excited to offer our customers a comprehensive solution, like Tiger Shark, that embodies our focus on cutting-edge technology,” said David Hannah, Director of Product Development at ChoiceSpine. “Along with our proprietary BioBond porous structure, Tiger Shark exhibits all of the necessary traits for powerful osseointegration, enhanced imaging properties, and solid biomechanical stability,” he continued.

Tiger Shark, which received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) in January 2018, was designed to help surgeons restore sagittal balance with an interbody device that offers good post-operative radiographic assessment and favorable osseointegration possibilities. “The Tiger Shark design capitalizes on the additive manufacturing process, which yields an extra-large graft volume, and a hydrophilic nanosurface that will complement our biologics portfolio,” said Dr. Stephen Ainsworth, Executive Vice President of Strategy and Technology at ChoiceSpine.

About ChoiceSpine
ChoiceSpine is a privately held spinal implant company located in Knoxville, TN. Founded in 2006, Choice offers an extensive array of innovative, surgeon focused systems designed with the best clinical outcomes in mind. In addition, ChoiceSpine offers a full regenerative and osteobiologics portfolio including synthetics, DBM’s, structural allograft, and amnion allografts. With cutting edge technology in their Veo™ VLIF lateral fusion line to the incorporation of Hydroxyapetite (HA) in their PEEK® interbody systems, ChoiceSpine is committed to always staying ahead of market trends and to provide surgeons with dynamic solutions for their patients.

Zimmer Biomet Partners with Faith In Practice to Improve Access to Musculoskeletal Care in Guatemala

Posted On April 30, 2018 By OrthoSpineNews In Recon, Top Stories /

WARSAW, Ind., April 30, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced today that it has entered into a partnership agreement with Faith In Practice, a Houston-based non-profit organization that provides surgical, medical, dental and educational programs in Guatemala. Under the partnership, Zimmer Biomet will donate instrument sets and provide implants for Faith In Practice to place in inventory with the goal of improving access to total knee arthroplasty procedures for patients in underserved communities.

Through the partnership’s model, Faith In Practice will utilize Zimmer Biomet implants at the Las Obras Hospital in Antigua and Hilario Galindo Hospital in San Felipe, Retalhuleu, Guatemala.

“This is an outstanding partnership of two organizations that are focused on the health of those in need in developing countries such as Guatemala,” said Brian S. Parsley, M.D., lead orthopaedic surgeon and member of Faith In Practice’s board of directors. “Zimmer Biomet has been supportive of our medical mission work for many years, and this agreement will further our capacity to treat those patients in need and offer them an opportunity to walk comfortably, remain active and provide for their families. This partnership will allow our surgeons to reach out and help even more patients due to the availability of implants and equipment. Our surgeons are ecstatic about this relationship.”

“We are delighted to partner with Faith In Practice,” said Dan Williamson, Zimmer Biomet’s Group President, Joint Reconstruction. “This opportunity enables us to continue to provide our innovative products and solutions in a socially impactful manner and further expands our ongoing efforts to help improve the lives of people in underserved communities who typically do not have access to healthcare advancements.”

“We are incredibly grateful to Zimmer Biomet for making this commitment to serve those in great need in Guatemala. While Zimmer Biomet has always been generous in supporting medical volunteers who wish to serve those in need in developing nations, this new way of providing implants will leverage and expand its impact significantly. We applaud Zimmer Biomet’s efforts and are honored to be its first partner in this new way of providing care to those who otherwise would have no access,” said the Rev. Linda McCarty, President and Chief Executive Officer of Faith In Practice.

About Faith In Practice
The mission of Faith In Practice is to improve the physical, spiritual, and economic conditions of the poor in Guatemalathrough short-term surgical, medical, and dental mission trips and health-related educational programs. Faith In Practice’s life-changing medical mission is to minister to the poor, while providing a spiritually enriching experience for its volunteers. Each year, more than 1,300 US volunteers serve through Faith In Practice, covering their own costs, taking vacation time, to serve. They are joined by more than 1,000 Guatemalan volunteers and two non-profit Guatemalan hospitals to provide care to the poor of Guatemala. For more information, visit www.faithinpractice.org.

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.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

Meditech Spine expands its lumbar plating options by adding the CURE LP iView and QMax to its growing portfolio of spinal implants

Posted On April 30, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ATLANTA, April 30, 2018 /PRNewswire/ — Meditech Spine, LLC, announced today it has received additional 510(k) clearance for its CURE Lumbar Plating (LP) System from the US Food and Drug Administration (FDA). The CURE LP iView and Cure LP QMax System clearance compliments Meditech’s recent 510(k) of the CURE Lumbar Plate System in 2017 with additional plating options. The CURE LP allows surgeons to utilize the lumbar plating system along with its novel lumbar Talos® fusion devices, which are manufactured with the PEEK-OPTIMA™ HA Enhanced polymer.

The CURE LP is a low profile titanium plate that incorporates a proprietary, one-step locking mechanism to prevent screws anchored on the spine from loosening and backing out. The special 510(k) includes additional sizing options for surgeons. The CURE LP-iView is similar to the standard CURE LP anterior plate but includes a through hole with rib to nest with the Talos®-A (HA) Interbody Device. And, the CURE LP-QMax is a four hole direct lateral plate complimenting the previously cleared two hole plate. The CURE LP anterior plates, sacral plates and the new iView and Qmax plates will be combined in one tray with streamlined instruments to make it easier on hospital and surgery centers to process the system. All systems will be provided sterile packaged to aid with implant tracking while helping to reduce implant related infections. The CURE Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach.

With the introduction of the CURE Anterior Cervical Plating (ACP) last year, Meditech continues its philosophy of giving back which led to a partnership with CURE International, the namesake of the CURE ACP and CURE LP, an organization that serves children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate will help CURE International treat patients in underserved areas who are in need of surgical care.

“After the introduction in late 2017 with our CURE LP system, we have continued to listen to surgeons and build upon our existing platform by providing additional plating options. Surgeons now have the flexibility of choosing from multiple plate configurations for their patients that require supplemental fixation. When coupled with our Talos®-A (HA) Interbody Fusion Device, manufactured with our next generation osteoconductive polymer, we provide a full and robust system for surgeons who utilize the anterior and anteriorlateral approaches to treat degenerative spinal conditions,” Eric Flickinger, Co-founder of Meditech Spine, noted.

For more information visit Meditech Spine.

ABOUT MEDITECH SPINE, LLC

Meditech Spine, LLC, is a spinal device company developing innovative instrumentation for treating complex spinal issues. It partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. Meditech’s pursuit of novel and innovative technologies drives its design and development team. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best available technologies.

CONTACT

Meditech Spine, LLC
(678) 974-5287
support@meditechspine.com

Caption & Copyright:

SOURCE Meditech Spine, LLC

New PROTI 360° Family of Implants from DePuy Synthes Is Designed to Enhance Spinal Fusion Surgery Outcomes

Posted On April 27, 2018 By OrthoSpineNews In Spine, Top Stories /

RAYNHAM, Mass., April 26, 2018 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announces the U.S. launch of the PROTI 360° Integrated Titanium Family of interbody devices to advance care for patients who have degenerative disc disease in the neck and back. This new offering underscores the commitment of DePuy Synthes to expand the company’s portfolio of interbody fusion devices designed to help improve outcomes after spinal fusion surgery.

Approximately 400,000 patients undergo spinal fusion surgery annually to help reduce pain and nerve root inflammation in the US alone.¹ During this procedure, a disc is removed and an interbody spacer is implanted to potentially restore natural height between two vertebrae and create solid bone.

To maximize the potential for bone growth following this type of surgery, DePuy Synthes has introduced the PROTI 360° Integrated Titanium Family of Implants, the only titanium-integrated Polyetheretherketone (PEEK) that offers 360 degrees of titanium integration. PEEK is a biocompatible material with mechanical properties that resemble human bone, and the implants are radiolucent, which means surgeons can easily assess the bone healing process over time.²The new PROTI 360° Technology offering combines the benefits of PEEK and titanium in each device. The titanium integrated surface of the PROTI 360° Family of Implants creates a bioactive surface that promotes the attachment and growth of bone-forming cells.^3,4

Data presented at a recent podium presentation during the International Society for the Advancement of Spine Surgery Meeting showed calcium deposition, which is an indicator of early bone formation, was 470.4% higher with the PROTI 360° Technology than PEEK alone and 305.1% higher than titanium alone just one day after device testing.⁵ The PROTI 360° Family of Implants is designed with enhanced bond strength between the materials, fortified titanium edges, and no exposed corners to prevent delamination, a process in which titanium coatings separate from the PEEK implant where the two materials meet.

“The ability to maximize the potential for bone growth is fundamental to achieving the best possible patient outcomes in most reconstructive spinal fusion surgery,” said L. Erik Westerlund, MD, Surgeon and Director of the St. Francis Spine Center, Columbus, Georgia***. “Utilizing innovative biomaterials like titanium-integrated PEEK designed to promote bone growth delivers a comprehensive alternative offering to surgeons that advances the standard for spine surgery patients.”

The PROTI 360° Family of Implants includes the ACIS PROTI 360° System for cervical fusion and the T-PAL PROTI 360° System and CONCORDE PROTI 360° System for lumbar interbody fusion. The PROTI 360° Systems are compatible with ACIS, T-PAL and CONCORDE Systems instrument sets.

“With the launch of the PROTI 360° Family of Implants we are responding to the needs of spine surgeons with a differentiated technology to help advance the care of patients undergoing spinal fusion surgery,” said Nadav Tomer, Global Platform Leader, DePuy Synthes Spine. “DePuy Synthes has one of the broadest spine portfolios in the world, and we continue to focus on innovation that strengthens our offering.”

About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, 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.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.
***Consultant to DePuy Synthes Spine

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the PROTI 360° Integrated Titanium Family of interbody devices. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes, the Johnson & Johnson Medical Devices Companies, nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

¹Rajaee, Ss et al. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine. 2012 Jan 1;37(1):67-76.
²Nemoto, O. et al. Comparison of fusion rates following transforaminal lumbar interbody fusion using polyetheretherketone cages or titanium cages with transpedicular instrumentation. Eur Spine J. 2014 Oct;23(10):2150-5.
³Lincks, J. et al. Response of MG63 osteoblast-like cells to titanium and titanium alloy is dependent on surface roughness and composition. Biomaterials 19, 1998. Pages 2219–32
⁴Kurtz, S. M. & Devine, J. N., PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomaterials. 2007
⁵TR-201801-B (ProTi Test Report)

089999-180411

SOURCE DePuy Synthes

OrthoSpineNews Interview with Lane Major, Chief Operating Officer at K2M

Posted On April 25, 2018 By OrthoSpineNews In Spine, Top Stories /

Good morning Lane, thank you for taking some time to talk with us this morning. If you wouldn’t mind introducing yourself to our readers and telling us a bit about your background to get started…

Sure thing, Mason. I truly appreciate the opportunity to share our K2M story with you. I have spent my entire career in the spinal devices space, beginning with a field-based role in Northern Virginia carrying primarily Stryker products. I was also exposed to several Globus products and some osteobiologics. Being in the operating room each day gave me a strong foundation in the spine industry. One that I keep with me today.

In January 2004, K2M was founded with a vision of improving the lives of people across the world with spinal deformities. I’ve been with the company ever since and am grateful for the work we do each day.

Thanks for that background, Lane. What is your biggest motivator for coming into work every day at K2M?

When you are with a company that changes lives—particularly for children suffering from scoliosis—seeing the positive impact of our work is all that matters. The societal value we create has resulted in a corporate culture second to none. It’s something you feel when you walk through the door. We hear this all the time from surgeons and others who visit us from around the world.

Our commitment to social good begins in Loudoun County, VA—our global headquarters—as well as at a national and global level. One example is a program called Straight 2 Swimming. Just imagine children with scoliosis who never could swim because they’re embarrassed to take off their shirts. We help them build confidence; it’s a huge motivator for me. Another example is the FOCOS Hospital we helped found in Ghana. The fact that our products are used to treat the world’s most challenging deformity cases inspires us each day.

Wow, that is incredible, Lane. Thank you for sharing that with us. Furthermore, can you give us an overview of the various 3D Solutions K2M offers and how you first got into the space?

Absolutely. K2M is leading the way in the 3D printing of spinal devices. But this work started well before 3D printing became popular. It came about because we were seeking to overcome a challenge.

Because our products are used in 40 different countries around the world, we have gained valuable insights from surgeons on what tools they need to improve outcomes in patients. Years ago, we began hearing people talking about how there should be a better alternative to PEEK implants. So, we partnered with a team of global key opinion leaders to create the Alternative Materials Design Team. The design input from this team led us to solutions that simply couldn’t be manufactured traditionally. It required innovation.

To improve upon PEEK technology, we partnered with 3D Systems—the world’s foremost leader in 3D printing for medical purposes. Today, we have a world-class portfolio of 3D-printed devices that address a diverse range of degenerative, complex spine, and MIS procedures. All of which feature our innovative Lamellar 3D Titanium Technology™, which uses an advanced 3D-printing method to create structures that were once considered impossible with traditional manufacturing. It allows us to develop devices with a porosity and surface roughness that pre-clinical data have associated with bone growth activity, as well as a decreased radiographic signature. All of which help improve outcomes in patients undergoing spine surgery.

Having said that, what is your vision for where the company goes from here?

Our vision is to be the leader in complex spine and minimally invasive solutions. We have had consistently strong success in these areas, and today, patients and physicians are asking us to help in the other areas of treatment. Therefore, we are introducing new technologies—such as our Balance ACS® (BACS) platform—to help surgeons and patients in all phases of preoperative, intraoperative, and postoperative patient care. Balance ACS is game-changing, as it uses a 360-degree approach to the axial, coronal and sagittal planes so surgeons can take a more holistic and comprehensive approach to treatment. It also includes a suite of data management software that lets surgeons collect and analyze patient data to improve treatment.

As we move forward, we will continually find ways to drive costs down for the patient, make practices more intuitive for surgeons, ensure faster recovery time, and much more.

We are really looking forward to seeing everything that lies ahead for K2M. Can you leave us with some closing remarks or any predictions about the spine industry as a whole?

There remains a significant opportunity for innovation in the spinal devices space. K2M is at the forefront of inventing solutions for the full continuum of care, not just limited to implants and instrumentation. The opportunity for innovation remains robust; we believe that K2M is well-positioned to position to continue leading.

Well Lane we really appreciate you taking the time to chat with us today. It was great to get some insights into the K2M story as well as what’s on the horizon. We wish you all the best moving forward.

Thanks Mason, likewise. We really appreciate the opportunity. Take care.

First European robotics-assisted total knee replacement performed with Smith & Nephew’s NAVIO™ Surgical System

Posted On April 25, 2018 By OrthoSpineNews In Recon, Top Stories /

24 April 2018

Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, announces that Spire Bushey Hospital in the UK, has completed Europe’s first robotics-assisted total knee replacement procedure using the NAVIO^◊ Surgical System.

Consultant Orthopaedic Surgeon Mr Richard Carrington, MBBS, FRCS (Orth), performed the first surgery using the Smith & Nephew JOURNEY^◊II Total Knee System.

The Smith & Nephew NAVIO Surgical System is a next generation handheld robotics platform designed to aid surgeons with component positioning, ligament balancing and bone preparation – key factors that may drive implant survivorship.^1,2 NAVIO is designed to help the surgeon with surgical planning and balancing of the joint to the patient’s specific needs. The handheld instrumentation uses multiple control modes to help the surgeon accurately prepare the bone for implantation.

The small footprint of NAVIO allows for easy set up and portability. Furthermore, NAVIO does not require a preoperative image, such as a CT scan. This allows patients to receive the benefits of robotics-assistance without the extra steps, costs, and radiation associated with additional preoperative imaging.³

“We are proud to support Spire Bushey in being the first hospital in Europe to bring patients the benefits of a robotic-assisted total knee procedure using the NAVIO Surgical System,” said Massimiliano Colella, President Europe and Canada, Smith & Nephew. “It is an important innovation as 80% of all knee replacement surgeries globally are total knees⁴, and it is exciting that Spire’s patients can now benefit from the improvements in accuracy that robotics is designed to deliver.”

Enquiries

Media

Dave Snyder
+1 (978) 749-1440
Smith & Nephew plc

References

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to supporting healthcare professionals in their daily efforts to improve the lives of their patients. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has more than 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

For more information about Smith & Nephew, please visit our corporate website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com

About Spire Bushey Hospital

Working with leading consultants in their field, we have become the private hospital of choice for knee replacements in London and our region. Across both 2016 and 2017*, more knee replacements were carried out at Spire Bushey than any other private London hospital. Our team of expert physiotherapists provide comprehensive pre-habilitation programmes to help strengthen the limb before surgery to improve recovery. They use the onsite gym and hydrotherapy pool to support patient rehabilitation following surgery.

^{Forward-looking Statements}

^{This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.}

^{◊ Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.}

NuVasive Sponsors AANS 2018, Hosts Workshops And Presentations On Latest Innovations

Posted On April 24, 2018 By OrthoSpineNews In Spine, Top Stories /

SAN DIEGO, April 24, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company is a sponsor of the American Association of Neurological Surgeons (AANS) Annual Scientific meeting being held April 28-May 2, 2018, in New Orleans, at the Earnest N. Morial Convention Center. NuVasive will host a hands-on workshop featuring the latest advances in Lateral Single-Position surgery, technology to reduce OR radiation and developments in 3D-printed implants.

The NuVasive Industry Lunch and Learn Workshop, Single-Position Lateral Surgery Solutions to Treat L4-S1, Featuring Advanced 3D-Printed Implants and LessRay® Radiation Emission Reduction Technology, by Kaveh Khajavi, M.D., Robert Issacs, M.D. and Juan Uribe, M.D., will take place on Monday, April 30 from 1:10-1:55 p.m. in Room 272-273. For more information, visit the AANS Program Schedule.

“The interactive workshop provides a forum to discover our commitment to Safer, Faster and Smarter surgery through Surgical Intelligence as well as our leadership position in Lateral Single-Position surgery and how it fits in with our industry-leading lateral procedural solutions,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “Lateral Single-Position benefits include reducing the number of times a patient has to be repositioned for greater OR efficiency. Attendees will hear directly from early adopters of the technology and also learn what NuVasive is doing to incorporate advanced materials into its surgical implants and how Surgical Intelligence includes proactively combatting radiation exposure in the OR with LessRay technology.”

Additionally, AANS attendees can visit NuVasive Booth #529 to experience the latest innovative spine solutions and systems firsthand from the NuVasive team of experts and meet NFL great and NuVasive spokesperson Archie Manning. The College Hall of Fame and former NFL Pro Bowl quarterback will discuss his firsthand experience with the life-changing NuVasive XLIF® procedure at the Lunch and Learn and in the booth on Monday, April 30. Manning continues to proudly share his personal story of how the XLIF spine procedure changed his life by restoring height and stability to the collapsed disc space on the left side of his lumbar spine. XLIF is the leading lateral spine procedure, supported by over 10 years of clinical evidence.

Individual NuVasive booth stations will focus on a variety of spine solutions, including Lateral Single-Position Surgery, Surgical Intelligence, Advanced Materials Science™, Cervicothoracic and TLIF.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Ortho Sales Partners Announces the Appointment of Chris Stewart as Senior Vice President and General Manager of Hospital Strategy

Posted On April 24, 2018 By OrthoSpineNews In Recon, Spine, Top Stories /

Ortho Sales Partners, the global leader in commercialization services for the orthopedic industry, is pleased to announce the addition of Chris Stewart to the companies executive team. Mr. Stewart is a very well regarded leader and innovator that brings an in-depth knowledge of the supplier, hospital and physician relationship. In addition to having a cross functional leadership role, Mr. Stewart will lead the organization and its clients in strategies related to hospital access and supply chain value analysis illustration as well as enhancing Ortho Sales Partners software and logistics platforms developed to optimize supply chain delivery and clinician user experience.

Prior to joining Ortho Sales Partners, Mr. Stewart was the Assistant Vice President and Business Unit Leader of Medical Device Management for HealthTrust. Mr. Stewart managed consulting services for hospital IDN memberships comprised of approximately 1,600 acute and 2,000 ASC facilities. He oversaw a team of orthopedic, spine, osteobiologic and cardiovascular specialists who worked with hospital clients to actively manage their clinically sensitive implant service lines. Using data as an asset, his team developed strategic roadmaps to help hospitals and physicians achieve financial and clinical alignment, so they could plan, not just react, to financial pressures and complex market changes.

Mr. Stewart holds a bachelor’s degree in economics and business administration from the University of Tennessee, Knoxville. He has presented at numerous healthcare forums on topics that include physician engagement, clinical best practice, alternative service models for the OR, strategic alliance of GPOs, shifting reimbursement models, new technologies, changing population demographics and the future of supply chain delivery.

About his new role, Mr. Stewart said: “I am excited to be joining this team of accomplished industry thought leaders who share the same vision and passion for enhancing value within this ever-changing healthcare environment”

Kevin McGann, CEO of Ortho Sales Partners, said: “We are very pleased to announce the addition of Chris Stewart to our team at Ortho Sales Partners. Chris is a well-respected healthcare executive, who has tremendous knowledge of the hospital networks, ambulatory surgery centers and group purchasing organizations. His experience in creating value added programs, and the utilization of data to direct purchasing behaviors is a tremendous asset to manufacturers, healthcare providers and physicians across the entire industry”

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About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations and produced results that have profoundly impacted each client’s business.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com).

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^{Forward-looking Statements}

NuVasive Sponsors AANS 2018, Hosts Workshops And Presentations On Latest Innovations

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Ortho Sales Partners Announces the Appointment of Chris Stewart as Senior Vice President and General Manager of Hospital Strategy