Implanet Announces the First Peer-Reviewed Publication of JAZZ® Results in Complex Adult Spine Surgery

Posted On May 2, 2018 By OrthoSpineNews In Spine /  

May 02, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

Implanet (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, is announcing the publication of a prospective study of JAZZ in complex adult deformity in the American Association of Neurological Surgeons’ Journal of Neurosurgery: Spine (JNS). These results were first presented at the North American Spine Society (NASS) Annual Meeting in October 2017.

Ludovic Lastennet, Implanet’s Chief Executive Officer, commented: “The publication in a leading industry journal of prospective results supporting the use of the JAZZ® platform as an alternative in the prevention of Proximal Junctional Kyphosis (PJK) demonstrates the substantial medical value added by JAZZ® in degenerative spine surgeries. The total addressable market for JAZZ® worldwide is very large indeed, with 400,000 implants(1) performed every year. Our JAZZ® platform, cleared for use in the United States and Europe, is ready to seize this market opportunity and to significantly broaden the scope of use in the treatment of adult spinal conditions.”

The preliminary results of the study by Dr. H. Francis Farhadi of the Ohio State University Medical Center on the “Prospective Assessment of Early Clinical and Radiologic Outcomes Following Sublaminar Band Placement for Proximal Junctional Kyphosis Prophylaxis in Adult Spinal Deformity Surgery” demonstrate that JAZZ® provides a promising alternative in the prevention of PJK in long-segment adult spinal deformity surgeries.

Despite the technological advances that now make it possible to correct severe sagittal malalignment and deformity, conditions arising from the wear and tear of adjacent segments, such as PJK and proximal junctional failure (PJF) remain of major concern. Surgeons employ a large number of surgical strategies: 65% of surgeons use PJK prevention strategies in over 40% of their patients(1). The results of Dr. Farhadi’s study show that using JAZZ can cut the percentage of patients developing PJK syndrome to 7.5% from the usual figure of 30% to 60% according to the literature.

Next press release: First-half 2018 sales on Wednesday, July 11, 2018

Implanet’s Combined General Meeting will be held at 10:00am on May 18, 2018 at the Company’s head office at Technopole Bordeaux Montesquieu, Allée François Magendie, 33650 Martillac. You are cordially invited to this event. For further information. Please send your contact details to the following email address: implanet@newcap.eu

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

1 The results of the 2014 SRS study in proximal junctional kyphosis (PJK) and proximal junctional failure (PJF), published in Number 11, Volume 40 of the SPINE review, pages 829 to 840, provide a valuable source of knowledge that can help to advance treatments for PJK and PJF.

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1 917 385 21 60
implanet@alphabronze.net

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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 SynergyTLIFSM 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

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Paradigm Spine Receives FDA Pre-Market Approval (PMA) For First Of Its Kind Disposable Instrument Kit

Posted On May 2, 2018 By OrthoSpineNews In Regulatory, Spine /  

NEW YORK, May 2, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced that the U.S. Food and Drug Administration (FDA) has granted pre-market supplemental approval (PMA) for its coflex® Interlaminar Stabilization®  disposable instrument kit. This marks the first approved disposable spinal instrument set for a Class III spinal device to receive a supplemental PMA approval, the most stringent type of device marketing application required by FDA.

coflex® Interlaminar Stabilization is Paradigm’s signature product and the exclusive posterior lumbar motion preservation solution with proven long-term outcomes for patients with moderate to severe spinal stenosis. The newly approved coflex disposable instrument kit offers a future additional option for implantation of coflex that is ideal in the outpatient setting of care. The kit will consist of a complete and simplified set of injection molded instruments delivered in a pre-sterilized peel pack.

“As a frequent user of coflex and experienced developer of several spinal disposable instrument sets, I am excited to have an additional resource approved for these procedures,” said neurosurgeon Richard N.W. Wohns, MD, JD, MBA, founder and president of NeoSpine, LLC in Puyallup, Washington. “Having a disposable coflex surgical kit will be ideal for simplifying and streamlining our operating room activities, particularly in ambulatory surgery centers. It’s a great value proposition to have reliable availability of instruments that are guaranteed sterile, saving labor costs in preparation time, increasing efficiency in the operating room, and diminishing potential infection risk vs. traditional reusable instruments.”

“We are thrilled to have the first PMA-approved disposable instrument kit for a Class III spinal device, and be able to offer this resource to our surgeon customers, further improving their experience with coflex,” said Marc Viscogliosi, Chairman and CEO of Paradigm Spine. “These kits are ideal for outpatient and ambulatory surgery centers because they are simple, disposable, sterile, and will reduce both financial and operational burdens on facilities. In addition, through a more streamlined manufacturing process, the kits are created to have a low carbon footprint, so they benefit physicians without causing excessive harm to the environment.”

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

Related Links

http://www.paradigmspine.com

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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.

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joimax® Launches Its Latest Interlaminar Endoscopic System, iLESSYS® Pro and New 4K Camera Light Source and Documentation Command System, Camsource® LED and Vitegra®

Posted On May 1, 2018 By OrthoSpineNews In Spine /  

May 01, 2018

IRVINE, Calif.–(BUSINESS WIRE)–joimax® again launches new product innovations at the upcoming American Association of Neurological Surgeons (AANS) taking place in New Orleans from April 28 – May 2, and at the Global Spine Congress (GSC) in Singapore, starting May 2. The German based market leader of technologies and training methods for minimally invasive endoscopic spinal surgery expands its family of decompression systems with an additional milestone of its interlaminar endoscopic access systems named iLESSYS® Pro for access and resection within the spinal canal. All endoscopic systems, including the members of the so-called iLESSYS® Family, will be shown at AANS as well as at GSC, where joimax® will host a full-day workshop with four stations on May 1 and with numerous lectures on endoscopic spine surgery held throughout the congress.

iLESSYS® Pro was developed in collaboration with Christoph Hofstetter, MD, PhD Associate Professor at University of Washington in Seattle, Washington. It combines the ability to efficiently remove and decompress degenerative spinal pathology from the iLESSYS® Delta with the possibility to enter the spinal canal and treat intraspinal disc pathology, which has been a hallmark of the iLESSYS® system. Along with TESSYS®, TESSYS® XT and TESSYS® Isee, now all lumbal and thoracic degenerative pathologies can effectively be treated with joimax® techniques.

“We have re-engineered every part of the iLESSYS® Pro, including dilators, rongeurs and drills with the goal to bring spine endoscopy one step closer to the efficiency of minimally invasive tubular spine surgery. Our patients benefit from the minimal tissue trauma associated with a small working corridor and a low complication rate achieved by superior visualization and illumination by working channel endoscopes. The new scope has completely surpassed my expectations and it is my go-to scope for interlaminar discectomies, medial facetectomies and certain laminectomies,” explains Dr. Christoph Hofstetter.

Also, Dr. Ralf Wagner from the Ligamenta Spine Center in Frankfurt, GER expresses his enthusiasm: “The working channel of 4.7 mm allows the use of larger forceps or blades for effective removal of hard tissue and, at the same time, is small enough to ideally suit for working within the spinal canal – really fantastic.”

At both congresses, the company will show its newest combined 4K resolution camera and LED light source system, Camsource®LED and its fully integrated documentation and command system, Vitegra® Docu and Command. They were presented for the first time at the Annual Meeting of the American Association of Orthopedic Surgeons (AAOS) in New Orleans in March.

With these innovations, joimax® again sets a major milestone worldwide. “With a significant growth rate in Q1/2018 we clearly demonstrate our leading role in endoscopic spinal surgery. We are still approaching our goal: to sustainably anchor the endoscopic minimally invasive spine surgery,” states Wolfgang Ries, Founder and CEO of joimax®. “This is also reflected in the increase of accepted lectures held at all congresses accompanied by a steadily growing number of publications.”

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® (for facet and sacroiliac joint treatment) or with EndoLIF® and Percusys® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

Press Contact USA :
joimax® Inc.
Melissa Brumley
Melissa.brumley@joimaxusa.com
001 949 859 3472

(Graphic: Business Wire)

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Medtronic Announces FDA Approval of Infuse(TM) Bone Graft in New Spine Surgery Indications Using PEEK Interbody Implants

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

DUBLIN – April 30, 2018 – Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of Infuse(TM) Bone Graft in new spine surgery indications. InfuseBone Graft is now approved for use with additional spine implants made of polyetheretherketone (PEEK) in oblique lateral interbody fusion (OLIF 25(TM) and OLIF 51(TM)) and anterior lumbar interbody fusion (ALIF) procedures at a single level. This is the second expanded indication in just over two years.

The new approved indications for InfuseBone Graft are:

  • Use in OLIF 51 procedures with Divergence-L®Interbody Fusion Device at a single level from L5-S1.
  • Use in OLIF 25 procedures with Pivox(TM) Oblique Lateral Spine System at a single level from L2-L5.
  • Use in ALIF procedures with Divergence-LInterbody Fusion Device at a single level from L2-S1.

“Different spine patients can have very different surgical needs, so the more options surgeons have to combine a clinically-proven bone grafting technology like Infuse with different procedures and implants, the greater the likelihood of successful outcomes,” said Dr. Richard Hynes, president and spine surgeon at the B.A.C.K. Center in Melbourne, Florida. “This latest approval addresses some fairly common degenerative spine surgical correction needs.”

InfuseBone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease. This condition can cause back and/or leg pain, as well as functional problems, such as tingling or numbness in the legs or buttocks or difficulty walking.

“Infuse Bone Graft remains one of the most-extensively studied products in Spine that is commercially available today,” said Doug King, senior vice president and president of Medtronic’s Spine division, which is part of the Restorative Therapies Group at Medtronic. “The expanded approval with these PEEK devices for OLIF25, OLIF51, and ALIF procedures provide important options for surgeons and their patients.”

InfuseBone Graft is approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries. Infuse has been on the market since 2002 and has been used in more than one million patients worldwide.

The active ingredient in InfuseBone Graft is rhBMP-2 – a manufactured version of a protein already present in the body that promotes new bone growth. During surgery, it is applied to an absorbable collagen sponge (ACS). The ACS is a carrier to deliver the rhBMP-2 to the implant site and acts as a scaffold for the formation of new bone, and it will resorb, or disappear, over time.

The Divergence-LInterbody Fusion Device and the Pivox Oblique Lateral Spine System incorporate the technology of Gary K. Michelson, M.D.

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

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Paradigm Spine Highlights Data Presented At ISASS 2018 Further Validating Decompression With coflex

Posted On April 30, 2018 By OrthoSpineNews In Spine /  

NEW YORK, April 30, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced results of three subanalyses from studies of coflex® that further validate the efficacy and benefit to patients with lumbar spinal stenosis. The data were presented during three scientific podium presentations at the 2018 International Society for the Advancement of Spine Surgery (ISASS), held April 11-13 in Toronto, Canada.

“coflex® is the only posterior lumbar motion preservation solution with proven long-term outcomes for patients with moderate to severe spinal stenosis,” said Marc Viscogliosi, Chairman and CEO of Paradigm Spine. “Five years after the FDA IDE study, these analyses demonstrate that coflex leads to decreased operative time, less blood loss, shorter hospital stays and overall is significantly less invasive than fusion. As a result, coflex is more cost-effective for the healthcare system while preserving positive clinical outcomes. These findings are substantial and important because they reflect real-world considerations surgeons take into account when treating patients.”

The first podium presentation “5-year Follow-up of Interlaminar Stabilization Surgery in the ≤ 65 Year Old Patient: More Value, Less Cost,” provided a sub-analysis of a cohort from the original multi-center, prospective, randomized, controlled Investigational Device Exemption (IDE) clinical trial that showed:

  • coflex was significantly less-invasive as measured by shorter operative times, decreased blood loss, and shorter length of hospital stay than fusion.

The lightning podium presentation “Medical Cost Savings for Lumbar Spinal Stenosis Treated with Decompression and Interlaminar Stabilization as an Alternative to Fusion” examined the potential economic impact of utilizing decompression with coflex versus decompression with fusion. The analysis showed:

  • fusion surgery is more than $50,000 more expensive per procedure, as compared to decompression with coflex.
  • coflex as an alternative to fusion in a clinically appropriate subset of LSS patients would favorably impact the total cost of care while preserving clinical outcomes.

A second lightning podium presentation “Comparison of Decompression with Interlaminar Stabilization vs. Decompression with Fusion in Patients Requiring Surgical Treatment for Spinal Stenosis Grade I Spondylolisthesis at 5 Year Follow-Up” provided a sub-analysis of a cohort from the FDA IDE trial comparing the efficacy of decompression with coflex versus decompression with fusion and concluded:

  • coflex is a significantly more cost-effective option for the healthcare system due to approximately half the operative time and a hospital stay that was almost two days shorter.

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

Related Links

http://www.paradigmspine.com

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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:

Talos® and Meditech logos are registered trademarks of Meditech Spine, LLC. All rights reserved.

PEEK-OPTIMA™ is a trademark of Victrex plc or its group companies. All rights reserved.

 

SOURCE Meditech Spine, LLC

Related Links

http://www.meditechspine.com

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CORRECTING and REPLACING Stryker to Highlight Expanding Line of 3D-Printed Tritanium® Cages at AANS

Posted On April 27, 2018 By OrthoSpineNews In Spine /  

April 27, 2018

ALLENDALE, N.J.–(BUSINESS WIRE)–Reference 3 should read “TREP0000053045 | Tritanium Wicking Verification Test.” (instead of RD0000050927 | Tritanium material capillary evaluation.). Also, Reference 4 has been removed.

The corrected release reads:

STRYKER TO HIGHLIGHT EXPANDING LINE OF 3D-PRINTED TRITANIUM® CAGES AT AANS

New Tritanium TL Curved Posterior Lumbar Cage to be previewed

Stryker’s Spine division will showcase its expanding line of Tritanium®cages, including the new Tritanium® TL Curved Posterior Lumbar Cage, a 3D-printed interbody fusion cage intended for use as an aid in lumbar fixation, at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, April 28–May 2, 2018, in New Orleans (booth No. 413).

Tritanium Cages are built using Stryker’s proprietary Tritanium In-Growth Technology,1 a novel, highly porous titanium material designed for bone in-growth and biological fixation.1 AMagine™ technology, Stryker’s proprietary approach to implant creation using additive manufacturing, allows for the production of randomized yet reproducible porous structures.2 The result is Tritanium Technology, which features an interconnected architecture with rugged irregular pore sizes and shapes that is designed to mimic cancellous bone.2 The Tritanium material also may be able to wick or retain fluid in comparison to traditional titanium material.3

According to Bradley Paddock, president of the Spine division, Tritanium cages have been well-received by surgeon users and continue to gain momentum. Since their launch, the Spine division has sold nearly 26,000 Tritanium Posterior Lumbar (PL) and Tritanium Anterior Cervical (C) Cages, combined.

“We are delighted to feature our growing family of Tritanium Cages at AANS this year and especially proud to introduce the Tritanium TL Curved Posterior Lumbar Cage,” Paddock said. “The new Tritanium TL Cage complements our Tritanium PL Cage, and together they offer alternative posterior lumbar solutions for spine surgeons and their patients.”

The Tritanium TL’s new Anterior Placement System and cage design combine to enable the surgeon’s desired apophyseal placement. The Tritanium TL Cage is shaped for steerability and has a unique, curved shape and rounded teeth to facilitate multidirectional fixation.

Stryker will host a Lunch-and-learn Seminar at AANS titled, “Evidence-Based Biomaterials in Spine,” on Monday, April 30 from 1:10–1:55 p.m. The seminar will be presented by Domagoj Coric, M.D., FAANS, neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, N.C.

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 stryker.com and builttofuse.com. Follow the Spine division on Twitter @stryker_spine.

References

1. PROJ43909 | Tritanium technology claim support memo.

2. Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.

3. TREP0000053045 | Tritanium Wicking Verification Test.

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

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.

Content ID: TRITA-PR-9_17426

Contacts

Sullivan & Associates
Andrea Sampson, 714/374–6174
asampson@sullivanpr.com

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New Spinal Stimulation Technology More Effective in Reducing Pain in Patients with Intractable Spine or Limb Pain Compared to Medical Treatment

Posted On April 27, 2018 By OrthoSpineNews In Spine /  

VANCOUVER, British Columbia, April 26, 2018 /PRNewswire-USNewswire/ — Spinal stimulation increases the odds of pain relief more than medical therapy when patients are faced with intractable spine or limb pain. In a recent study, researchers made the following discoveries: 1) spinal stimulation compared to medical therapy significantly increased the odds of reducing pain by 50%; 2) spinal stimulation compared to medical therapy significantly reduced pain as measured by Visual Analogue Scale (VAS); and 3) using the common comparator of medical therapy, newer stimulation technology (eg, HF10, Burst, DRG) led to increased odds of pain relief compared to conventional spinal stimulation.

Presented today in a scientific poster at the American Academy of Pain Medicine 34th Annual Meeting, this abstract intends to increase awareness about spinal stimulation as an option to treat chronic pain.

“Given the national opioid crisis, patients, physicians, policy makers, and payers are asking about viable alternatives to treat intractable pain. Spinal stimulation has demonstrated efficacy in a variety of difficult to manage chronic pain conditions,” says Tim Lamer, MD, of the Mayo Clinic who led the research.

“Our study is a comprehensive systematic review of the spinal stimulation literature spanning the past 30 years. We included only the highest quality studies consisting of Randomized Controlled Trials (RCTs). The results of our systematic review are that RCTs have demonstrated effectiveness and significantly greater odds of pain improvement with spinal stimulation compared to medical therapy in patients with painful diabetic neuropathy, complex regional pain syndrome, and pain in the setting of failed spine surgery. Recently published studies have shown that newer spinal stimulation technology such as dorsal root ganglion stimulation and Hf10 spinal stimulation compared to conventional spinal stimulation may have even greater success in achieving pain relief in properly selected patients.”

About AAPM
The American Academy of Pain Medicine is the premier medical association for pain physicians and their treatment teams with some 2,000 members. Now in its 35th year of service, the Academy’s mission is to advance and promote the full spectrum of multidisciplinary pain care, education, advocacy, and research to improve function and quality of life for people in pain. Information is available on the Academy’s website at www.painmed.org.

SOURCE American Academy of Pain Medicine

Related Links

http://www.painmed.org

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