Paradigm Spine Announces Company Activities Highlighting coflex® Interlaminar Stabilization® At NASS Annual Meeting 2018

Posted On September 24, 2018 By OrthoSpineNews In Spine /

NEW YORK, Sept. 24, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced its Company activities and scientific podium presentation on coflex^® Interlaminar Stabilization^® at the upcoming the 2018 North American Spine Society (NASS) Annual Meeting, being held September 26-29 in Los Angeles, Calif. coflex^® is the only posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability for patients with moderate to severe spinal stenosis.

“The annual NASS meeting provides an optimal opportunity to directly engage with our U.S. spine surgeon audience and we look forward to demonstrating – on the podium and through our surgeon reception – the substantial results adding up from both our newly published ESCADA study and long-term findings from the U.S. FDA IDE trial supporting coflex^® against decompression alone and against fusion, respectively,” said Marc Viscogliosi, Chairman and CEO of Paradigm Spine.

Details of Paradigm Spine’s activities below:

Oral Presentation: Interlaminar Stabilization versus PLF in the ≤ 65 Year-Old Patient: Five-Year Follow-Up
Abstract: # 91
Session: Preserving Spinal Motion; Session moderated by Richard D. Guyer, MD
Date, Time: Wednesday, September 26^th at 4:41-4:47 p.m. PDT
Location: Room 403A
Presenting Author: Antonio T. Brecevich, MD
Institutions: Hospital for Special Surgery (HSS), New York, NY
Product: Coflex (Approved for this indication)

Paradigm Spine Sponsored Surgeon Reception
Date, Time: Thursday, September 27^th at 5:30-8:00 p.m. PDT
Location: GRAMMY Museum at L.A. Live
800 W. Olympic Boulevard, Los Angeles, CA 90015
(a 3-minute walk from the Convention Center)

To learn more about coflex^® Interlaminar Stabilization^® and the newly-published ESCADA results, please visit Paradigm Spine at Booth # 1429 in the Exhibit Hall.

About Lumbar Spinal Stenosis (LSS)
Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion. Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

About Paradigm Spine, LLC:
Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company’s signature product is the coflex^® Interlaminar Stabilization^® device, which is currently used in over 60 countries worldwide. coflex^® is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

SOURCE Paradigm Spine, LLC

CoreLink Surgical Announces the launch of Articulating Expandable Posterior Lumbar System – FLXfit®15

Posted On September 24, 2018 By OrthoSpineNews In Spine /

September 21, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink Surgical today announces the expanded commercial launch for the FLXfit®15 articulating-expandable intervertebral body fusion device.

FLXfit15 is a posterior lumbar expandable interbody device that offers up to 15 degrees of controlled and continuous expansion and is one of the only expandable cages on the market that offers articulation, providing ease in precise anterior placement. FLXfit15’s open device architecture enables ample space for graft material and its bulleted-nose and single-instrument inserter/expander are designed to streamline insertion. FLXfit15 is offered in 2 lengths – 32mm and 40mm, and in heights from 8-13mm to accommodate diversity in anatomical need.

“The FLXfit15 Interbody device offers the surface area contact and lordosis often desired in an ALIF procedure but obtained with a less complicated posterior approach – this implant is inserted as a PL, deploys as a TL, and expands to gain lordosis of up to 15 degrees. It saves me time, is less invasive and offers optimal sagittal balance correction. In my opinion, it’s the best posterior interbody cage on the market,” said Grant Skidmore MD, Neurosurgeon, Norfolk, VA.

Jay Bartling, CEO, said, “The surgeon and distributor interest in FLXfit15 has far exceeded expectations in a very short period. CoreLink is committed to providing advanced technology with world class quality.”

“Last year, expandable devices grew to over 20% of the overall interbody market- expandable devices are clearly here to stay. CoreLink’s offering FLXfit15 is a great compliment to our growing product offering and positions us well to meet the increasing needs of surgeons and patients,” said Derek Kuyper, VP of Sales at CoreLink.

CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, booth #2038, where a full display of FLXfit15 and our family of Foundation 3D Products will be featured. Private appointments available.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering its surgeons and improving the lives of their patients.

Be a part of something at The Source.

Photo: Business Wire

Contacts

CoreLink, LLC
Courtney Sheedy, 888-349-7808
www.corelinksurgical.com

Biedermann Motech to launch iMAS 360™ procedure at NASS

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

Miami, FL – September 24, 2018 / Business Wire / – Biedermann Motech will launch the iMAS 360™ procedure at NASS 2018 in Los Angeles, September 26-28, 2018.

Biedermann Motech, the developer of the world’s first polyaxial pedicle screw (MOSS System) and pioneer in the spinal market for more than 30 years, announced today the launch of the iMAS 360™ procedure at the North American Spine Society (NASS) meeting in Los Angeles, September 26-28, 2018.

The iMAS 360 is a mini-open, microsurgical 360 fusion procedure for the lumbar spine developed by spinal surgeon Robert L. Masson, M.D., Orlando. It incorporates many of the traditional fusion techniques combined with advanced implants and instruments to create a less invasive muscle sparing procedural solution. The key takeaway of the iMAS 360 is the ability to treat any level of the lumbar spine between L2 and S1 with one small posterior midline skin incision.

“iMAS 360 is a lumbar fusion technique that is tissue sparing, has an optimized surgical field, allows for bilateral direct decompression and restoration of lordosis. The MOSS 100™ modular pedicle screw system and the TELIX K™ steerable interbody system have been specifically designed with the iMAS 360 procedure in mind,” says Ray Oktavec, Biedermann Motech’s Director of US Sales & Marketing, Spine.

Robert L. Masson, M.D., said, “The iMAS 360 evolved over time to optimize accuracy, strategy, sequence and ultimately systems. It is an advanced procedural solution integrating technologically sophisticated equipment and techniques focusing on a specific 3D reconstructive plan…”

There will be presentations for surgeons discussing the clinical value of the iMAS 360 procedure at the Biedermann Motech booth # 2435 all three days during NASS with Robert L. Masson, M.D., Tim Keenen, M.D., Syed Aftab, FRCS, and PD Dr. med. Ali Reza Fathi.

More information is available at www.biedermann.com or call 866-622-6082.

About Biedermann Motech

Biedermann Motech is a mid-sized, family owned group of companies with headquarters in Germany (Villingen-Schwenningen) and the USA (Miami). Since 1916 we have been working in synergy with world-class surgeons to solve significant clinical challenges through the development of next-generation technology. Our core competence is the development, production, and distribution of innovative implants and instruments for spinal and extremity surgery. We research, develop, manufacture and distribute high-quality implant systems in collaboration with healthcare professionals, technology partners, scientific institutions and specialized companies with the goal of achieving improved clinical outcomes.

Contact: Serina Prado

305-722-5310 x132

sprado@biedermann.com

Biedermann Motech, Inc – USA

7620 NW 25^th Street, Unit 3 & 4

Miami, FL 33122

Biedermann Motech GmbH & Co. KG
Bertha-von-Suttner-Str. 23
78054 Villingen-Schwenningen

Germany

stryker-tritanium-3d-printed-lumbar-cage-gets-fda-approval-1.jpg

Stryker’s Spine Division To Showcase Tritanium® In-Growth Technology in Augmented Reality Experience at NASS 2018

Posted On September 21, 2018 By OrthoSpineNews In Spine /

September 20, 2018

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will feature its family of 3D-printed Tritanium interbody fusion cages and highlight its Tritanium In-Growth Technology¹ in an augmented reality experience at the North American Spine Society Annual Meeting, Sept. 26–29, 2018, in Los Angeles (booth No. 1401).

The augmented reality “tour” combines objects in the real world with computer-augmented 3D animations. Using this augmented reality storyline, as well as a series of hands-on activities and scientific animations, the experience at the Stryker booth is designed to enhance understanding of the story behind Tritanium In-Growth Technology, as well as AMagine™, Stryker’s proprietary additive manufacturing (or 3D-printing) process, which assists in the creation of highly porous implants with a structure that is designed to mimic bone.

“Our augmented reality tour will demonstrate Tritanium’s characteristics, with the goal of helping surgeons better understand the differences of materials on the market,” said Michael Carter, vice president and general manager of Stryker’s Spine division. “Tritanium continues to receive terrific feedback as more surgeons become believers in the technology, validating our commitment to providing advanced and innovative products for our surgeon customers and their patients.”

Tritanium cages are inspired by the microstructure of cancellous bone¹ and enabled by AMagine, Stryker’s proprietary approach to implant creation using additive manufacturing. The AMagine process allows the company to tackle previously difficult or impossible design complexities and address unmet surgeon needs with unique material characteristics. For example, Tritanium may be able to wick and retain fluid inside its porosity, compared to traditional titanium.^1,2 Additionally, the unique porous structure of Tritanium Technology was designed to create a favorable environment for bone cells to attach and proliferate.^3,4*

During the NASS conference, Stryker will also:

Feature results of a recent comparative animal study, which found significant differences in biomechanical and histologic performance among various interbody cage materials. The results showed that Tritanium cages achieved statistically significant increases in bone in-growth.⁴
Present a Solution Showcase titled “A Clinical Update on Tritanium—A Novel, Highly Porous Material Designed for Bone In-Growth and Biological Fixation,” by Scott Parker, M.D., assistant professor of neurological surgery, Vanderbilt University Medical Center, on Sept. 26, 2018, from 12–12:20 p.m. PT.
Preview its new Tritanium TL Curved Posterior Lumbar Cage, which received 510(k) clearance from the U.S. Food and Drug Administration in January 2018. Click here for the indications for use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com and www.builttofuse.com. Follow Stryker’s Spine division on Twitter @stryker_spine.

References

1.		Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials. 2005;26, 5475-5491.
2.		RD0000053710: Tritanium cell infiltration and attachment experiment.
		*No correlation to human clinical outcomes has been demonstrated or established.
3.		RD0000050927: Tritanium material capillary evaluation.
4.		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.

CONTENT ID TRITA-PB-4

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Dr. Parker is a paid consultant of Stryker. His/her statements represent his/ her own opinions based on personal experience and are not necessarily those of Stryker. Individual results may vary.

Contacts

Stryker’s Spine Division
Jodie Morrow
Jodie.morrow@stryker.com
or
Sullivan & Associates
Andrea Sampson
asampson@sullivanpr.com, 714/374–6174

Green Sun Medical Celebrates Spine Technology Award, Scoliosis Brace Company Continues Helping Kids

Posted On September 20, 2018 By OrthoSpineNews In Spine /

Fort Collins, CO., 9/20/18 – Green Sun Medical LLC., a medical device company specializing in scoliosis bracing, announced that it has been selected to receive Orthopedics This Week’s Spine Technology Award during the 2018 National Association of Spine Surgeons (NASS) Meeting in Los Angeles, CA. Green Sun Medical has developed a comfortable, dynamic brace which applies continuous corrective pressure to the spine of adolescent patients with scoliosis. The brace will provide physicians and patients with real-time performance metrics utilizing a cloud-based health platform developed by Mindset Medical LLC.

Commenting on the company’s latest award, CEO Jamie Haggard said, “Winning the Spine Technology Award is the dream of every entrepreneur who works in the spine industry. Our goal is to provide a transformative scoliosis treatment experience for children. Creating a better quality of life and clinical outcome is now one step closer for adolescents who are coping with this disease.”

To meet our goal, Green Sun Medical has assembled a team of the world’s thought leaders in scoliosis treatment. The company is executing a carefully planned clinical study beginning at the National Scoliosis Center and continuing at the Shriner’s Hospital for Children in Sacramento, CA.

About Green Sun Medical:

Green Sun Medical is based in Fort Collins, CO. Founded in 2015, the company has developed a connected dynamic scoliosis brace. It has won numerous prestigious awards including; the FDA sponsored Pediatric Device Symposium, SXSW Pediatrics Device Competition and a $200,000 prize for best medtech innovation from the Medtech Innovator. www.greensunmedical.com

Attachments

Jamie Haggard
Green Sun Medical 
970-215-3291
jamie@greensunmedical.com

NuVasive To Showcase Spine Precision Surgery Leading To Smarter, More Predictable Clinical Outcomes At NASS 2018

Posted On September 20, 2018 By OrthoSpineNews In Spine /

SAN DIEGO, Sept. 20, 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 it will highlight the Company’s latest disruptive spine technology at the North American Spine Society (NASS) Annual Meeting held September 26-29, 2018 in Los Angeles, California, at the Los Angeles Convention Center.

“Now more than ever, NuVasive is expanding its portfolio with innovative launches covering spine’s leading procedures, materials and systems,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “NuVasive is fully committed to furthering its R&D investment and bringing disruptive technology to market to meet the needs of our surgeon partners to provide better and more predictable outcomes for patients.”

At the annual meeting, NuVasive will highlight its commitment in developing spine precision surgery advancements in key focus areas:

Surgical Intelligence™ is an ecosystem of integrated, modular technologies to deliver safer, faster and smarter surgery. A key part of this ecosystem is LessRay^®, a stand-alone proprietary technology that enhances low-dose, low-radiation fluoroscopy (or x-ray) images to have similar diagnostic capabilities as conventional full-dose fluoroscopy images. With the evolution of Surgical Intelligence, LessRay will integrate into the Pulse™ surgical automation platform, a first-of-its-kind integrated spine system addressing a broad range of clinical challenges, with enhanced utility and intuitive workflow. This platform introduces 2D- and 3D-navigation and smart imaging capabilities along with the Company’s leading neuromonitoring, NuvaMap^® O.R. surgical planning, radiation reduction and patient-specific rod-bending technologies. Both systems will be available for live demonstrations at the meeting.
Lateral Single-Position Solutions are intended to decrease the amount of time a patient is under anesthesia and increase operating room efficiency by reducing the need for patient repositioning. This is built on the foundation of the Company’s XLIF^® procedure and is supported by extensive clinical evidence with more than 400 peer-reviewed, XLIF-specific publications. NuVasive’s proprietary instrumentation and fixation expand the benefits of lateral surgery to more spinal levels from T6-S1, compared to traditional lateral procedures, by providing direct access to the L5-S1 level from a lateral position.
Advanced Materials Science™ (AMS) Interbody Portfolio is designed to deliver enhanced osseointegration and biomechanics through innovative implant design and superior surface, structure and imaging characteristics. The Company’s recently launched TLX^® 20 degree expandable spinal interbody implant with a first-of-its-kind oblique profile designed for transforaminal lumbar interbody fusion (TLIF) procedures will be on display, and demonstrates the Company’s commitment for further development of a full suite of expandable cage technologies. NuVasive is the only company to offer four specific materials for spinal interbodies: traditional PEEK (polyetheretherketone), propriety porous PEEK, titanium and 3D-printed porous titanium.
Intraoperative Neuromonitoring (IONM) For the first time, the NASS Annual Meeting will include an IONM symposium where surgeons can learn more about the utility, evidence and value of neuromonitoring in spine surgery, along with moderated abstract presentations. NuVasive’s clinical services division is the nation’s largest provider of outsourced IONM services, and the Company will demonstrate its neuromonitoring capabilities through its Pulse platform.

NuVasive 2018 NASS Annual Meeting Participation Details
NuVasive will showcase its innovation in Booth #2301 at the NASS Annual Meeting, as well as host several clinical workshops and participate in numerous podium presentations demonstrating the Company’s commitment to high-quality studies to advance the full application of its spinal solutions.

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.

Safe Orthopaedics Announces the Commercial Launch of SteriSpineTMVA, a Balloon for the Vertebral Augmentation

Posted On September 18, 2018 By OrthoSpineNews In Spine /

September 18, 2018

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR) (Paris:SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments for back surgery, today announces its worldwide launch of its Kyphoplasty System: the SteriSpine^TM VA.

The new system adds to an already existing portfolio of sterile & single use devices and establishes Safe Orthopaedics as the only company that can offer a comprehensive portfolio of ready to use spinal fracture treatment options, which consists of a balloon and cement systems for restoring the vertebral body and a complete range of implants for stabilizing the spinal segment (Screw, rod, cross connectors…) post-fracture…

The European market for the treatment of vertebral compression fractures (VCF) via vertebral augmentation (Kyphoplasty) is estimated at €82M in 2018 and is expected to grow to over €120M in 2026¹ with a CAGR of 4.8%, in large part, because of the ageing population in Europe.

Sjors Hermans, Global sales director of Safe Orthopaedics comments: “The SteriSpine^TM VA is one of the two first systems in the market to offer a high quality, high pressure balloon of 700 PSI. Safe Orthopaedics is now the only one in the world to propose a full ready to use spinal treatment for the vertebral fracture.”

Pierre Dumouchel, CEO of Safe Orthopaedics, concludes: “Reinforcing our leadership in the fracture segment, we address a new segment representing €72M in France, Germany and the UK that will sustain our strong growth and reinforce our gross margin.”

In last July, Safe Orthopaedics announced the launch of its kyphoplasty offer in the countries where Safe Orthopaedics has a direct sales force. From September 2018, this offer is extended to all countries where the Safe Orthopaedics is present. This cement injection method, performed with a balloon, allows Safe Orthopaedics to provide a complete emergency fracture treatment package to push the penetration of its products towards the surgeons and strengthen its gross margin.

The SteriSpine^TM VA balloon is a high pressure, high quality balloon that can be inflated up to 700 PSI. The majority of the systems in the market today allow between 300 and 400 PSI. It comes in different sizes to accommodate all different kinds of patient anatomy.

¹ 2017 Millennium Research data

Next financial publication: First half 2018 results, September 28, (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 37 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
François-Henri Reynaud, Tel. : +33 (0)1 34 21 50 00
Chief Financial Officer
investors@safeorthopaedics.com
or
Investor relations
NewCap
Valentine Brouchot, Tél. : +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu
or
Press Relations
Ulysse Communication
Bruno Arabian, +33 (0)6 87 88 47 26
barabian@ulysse-communication.com
Nicolas Daniels, +33 (0)6 63 66 59 22
ndaniels@ulysse-communication.com

NuVasive Announces UK Launch Of MAGEC® X For Early Onset Scoliosis Treatment

Posted On September 18, 2018 By OrthoSpineNews In Spine /

SAN DIEGO, Sept. 18, 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 United Kingdom (U.K.) launch of MAGEC^® X, the newest product generation within the MAGEC pediatric portfolio that addresses early-onset scoliosis (EOS).

The development of MAGEC X is distinguished by the inclusion of 5.0mm diameter patient rods, delivering a 68 percent improved fatigue-strength performance over the traditional 4.5mm option.ⁱIt also incorporates several advanced rod mechanisms, most notably a robust actuator seal designed to help further contain and reduce the release of titanium wear debris. Additionally, the rod includes an anti-jam feature to simplify intraoperative and postoperative rod lengthening. Key aesthetic improvements, such as laser-marked sagittal bending lines, help to enhance surgeon workflow efficiency and ease of use.

“I am extremely impressed with the NuVasive MAGEC X 5.0mm solution and its ability to provide superior rod strength without having to sacrifice the ideal fixation size thus meeting the clinical needs of pediatric patients,” said Dr. Stewart Tucker, MBBS, FRCS, orthopedic surgeon at Great Ormond Street Hospital in London, England. “Additionally, MAGEC X substantially improves intra-op workflow with enhanced ease of use. It provides surgeons with tremendous flexibility, enabling upsizing of rods while maintaining small screw heads, giving optimal profile and soft tissue cover.”

The 5.0mm growing rod in the MAGEC X system pairs with the NuVasive Reline^® Small Stature fixation system, the first pediatric deformity fixation solution that combines rod strength with low-profile implants. Together, the two systems help minimize the occurrence of revision surgeries by adding enhanced construct strength with an optimized low-profile for EOS patients.

“Following in the footsteps of our proven MAGEC solution, MAGEC X brings several new capabilities to the MAGEC portfolio and is a testament to NuVasive’s continuing practice of innovating and delivering next-generation spinal technologies for surgeons and patients in the pediatric space,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “MAGEC X’s 5.0mm rod is truly game-changing as it supports patients with a small implant profile, but with significantly increased fatigue strength over the previous generation.”

This U.K. commercial launch of MAGEC X follows the Company’s U.S. commercial launch which occurred in July 2018. The Company will also host a MAGEC Users Meeting in Lisbon, Portugal on November 16, 2018, following the International Congress on Early Onset Scoliosis (ICEOS) Annual Meeting. This global users meeting will bring together surgeons and surgical staff from around the world to discuss challenges, shared successes, and review best practices related to the use of MAGEC as a treatment for EOS.

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.

ⁱData on File: TR 9604057; dynamic 4-point bending testing per ASTM F2193.

Logo – https://mma.prnewswire.com/media/454552/NuVasive_Logo.jpg

SOURCE NuVasive, Inc.

Meditech Spine Receives FDA Clearance for its Cure™ Opel-C Plating System

Posted On September 18, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ATLANTA, Sept. 18, 2018 /PRNewswire/ — Meditech Spine has received FDA 510(k) clearance to market the Cure™ Opel-C Plate System, an add-on technology to its already cleared CURE™ ACP System and Talos®-C (HA) Interbody Systems. With this approval, Meditech will now offer two additional CURE™ ACP plating options with its Talos® line of cervical interbodies made with the osteoconductive PEEK-OPTIMA® HA Enhanced material. Since Meditech’s introduction of the CURE™ ACP System in late 2016, its adoption and usage have seen double-digit growth. By adding the Opel™-C plating options to the CURE™ ACP product line, surgeons now have two modular snap-on plate styles providing rigid fixation while minimizing adjacent level impact. The Cure™ Opel-C Plate System incorporates the same unique, patented, one-step locking mechanism of the CURE™ ACP System preventing screws from backing out when anchored in the vertebral body. Meditech will be demonstrating the newly approved system at the North American Spine Society (NASS) meeting held in Los Angeles, CA from September 26-28 along with its proprietary Talos® HA Peek Interbody Systems in booth 1757.

Meditech is excited to continue its relationship with CURE International, the namesake of the CURE™ ACP, an organization serving children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate helps CURE International treat patients in need of surgical care.

For more information visit Meditech Spine.

ABOUT MEDITECH SPINE, LLC

Meditech Spine, LLC, is a growing spinal implant company that partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best technologies available. Meditech’s belief in the spinal marketplace is to value and honor their partners and all who are touched by their interactions in the development and distribution process so that each experience leaves a positive impact upon those they serve.

CONTACT

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

Caption & Copyright:

SOURCE Meditech Spine, LLC

Photo: (PRNewsfoto/Meditech Spine, LLC)

SpineVision® Receives CE Mark for Next-Gen P.L.U.S.® Deformity-Correction Spinal System

Posted On September 18, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ANTONY, France–(BUSINESS WIRE)–SpineVision announced today that it has received CE mark for its next-generation Pivot Link Universal System (P.L.U.S.) spine deformity-correction system. SpineVision will introduce the next-generation P.L.U.S. to spine surgeons at “EuroSpine 2018” (Booth #24C) in Barcelona, Spain (Sept. 19-21), and “NASS 2018” (Booth #1311) in Los Angeles (Sept. 26-29).

Deformity of the spine includes any abnormality of the formation, alignment, or shape of the vertebral column. Diagnoses that are associated with spine deformity include scoliosis, spina bifida, Becker and Duchenne muscular dystrophy, kyphosis, and spondylolisthesis, among others. Spine stabilization surgery is recommended in cases where there is severe pain, neurological problems, or curvature greater than 50 degrees. The goal of surgery is to straighten and hold the spine straight. Several surgical techniques can be used, including spinal fusion and the use of implants such as the P.L.U.S. to secure the fusion.

“The introduction of our Pivot Link Universal System (P.L.U.S.) extends our successful track record of commercializing cutting-edge products encompassing all spine pathologies,” said Arnaud Brisard, CEO of SpineVision. “We believe that this next generation of an already successful product will be enthusiastically embraced by orthopedic surgeons, because the P.L.U.S. is designed to make every step of spine deformity surgery more facile for the orthopedic surgeon—especially correction maneuvers before final locking.”

CLICK HERE FOR THE COMPLETE VERSION OF THIS NEWS RELEASE.

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1 508-816-6730
rtrahan@ronaldtrahan.com

Spine

Paradigm Spine Announces Company Activities Highlighting coflex® Interlaminar Stabilization® At NASS Annual Meeting 2018

Related Links

CoreLink Surgical Announces the launch of Articulating Expandable Posterior Lumbar System – FLXfit®15

Contacts

Biedermann Motech to launch iMAS 360™ procedure at NASS

Stryker’s Spine Division To Showcase Tritanium® In-Growth Technology in Augmented Reality Experience at NASS 2018

Contacts

Green Sun Medical Celebrates Spine Technology Award, Scoliosis Brace Company Continues Helping Kids

NuVasive To Showcase Spine Precision Surgery Leading To Smarter, More Predictable Clinical Outcomes At NASS 2018

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Safe Orthopaedics Announces the Commercial Launch of SteriSpineTMVA, a Balloon for the Vertebral Augmentation

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NuVasive Announces UK Launch Of MAGEC® X For Early Onset Scoliosis Treatment

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Meditech Spine Receives FDA Clearance for its Cure™ Opel-C Plating System

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SpineVision® Receives CE Mark for Next-Gen P.L.U.S.® Deformity-Correction Spinal System

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