Lordosis

Accelus Announces Renewed Focus on Pioneering Minimally Invasive Outpatient Procedures with Its Advanced Adaptive Geometry Technology

Retrieved on: 
Thursday, December 7, 2023
Subsidence, Pain, PALM, ODI, BEACH, ASC, Surgeon, Visual analogue scale, Lordosis, Innovation, Geometry, Abdominal ultrasonography, Spine, Human, Patient, Oswestry Disability Index, Hospital

"We’re excited about the ongoing shift toward minimally invasive, awake and outpatient spinal fusion surgeries, as it allows a broader spectrum of patients to experience the benefits of these less invasive, more patient-centric procedures,” said Kevin McGann, President & CEO of Accelus.

Key Points: 
  • "We’re excited about the ongoing shift toward minimally invasive, awake and outpatient spinal fusion surgeries, as it allows a broader spectrum of patients to experience the benefits of these less invasive, more patient-centric procedures,” said Kevin McGann, President & CEO of Accelus.
  • This controlled, in-situ, multiplanar expansion is designed to restore foraminal height, reestablish sagittal balance and reduce subsidence, a common concern in spinal fusion procedures.
  • The recent article, " Backbones of Innovation Signal What's Next in Spine Care ," published in BoneZone, highlights Accelus's role in this transformation.
  • No implant-related complications, cage subsidence, cage migration or need for revision surgery were reported at the one-year mark for this study.

Spinal Elements® Announces Full Commercial Release of Ventana® 3D-Printed Interbody Portfolio

Retrieved on: 
Tuesday, November 28, 2023
Health, Surgery, Physical Therapy, Medical Devices, MIS, Lordosis, Spinal fusion, Interbody fusion cage, Sapphire, Multimedia, Orbit, MD, Element, Titanium, 3D printing, Medical imaging

Spinal Elements, a spine technology company, today announced the full commercial launch of their Ventana 3D-Printed Interbody Portfolio: The Ventana C Anterior Cervical Interbody System, Ventana P/T Posterior Lumbar Interbody System and Ventana L Lateral Lumbar Interbody System.

Key Points: 
  • Spinal Elements, a spine technology company, today announced the full commercial launch of their Ventana 3D-Printed Interbody Portfolio: The Ventana C Anterior Cervical Interbody System, Ventana P/T Posterior Lumbar Interbody System and Ventana L Lateral Lumbar Interbody System.
  • The Ventana portfolio was developed by Spinal Elements and is the newest innovation in its MIS Ultra® platform of products and procedural solutions.
  • View the full release here: https://www.businesswire.com/news/home/20231128294823/en/
    The Ventana® 3D-Printed Interbody Portfolio (Photo: Business Wire)
    The Ventana portfolio features a uniquely designed implant architecture that maximizes bone graft volume and containment through a specialized 3D-printing process, which also minimizes the amount of titanium used to improve radiographic visualization.
  • “Ventana represents another major milestone in our mission to redefine spinal healthcare.”
    The Ventana 3D-printed interbody portfolio was organically developed by the Spinal Elements team with input and guidance from multiple spine surgery thought leaders.

ATEC Advances Lateral Surgery With Launch of Expandable Technology

Retrieved on: 
Monday, October 16, 2023
Biotechnology, Surgery, Medical Devices, Health, Health Technology, EOS, CSA OrthoCarolina Sportsplex, PTP, NASS, LTX, Spine, Lordosis, Calibration, L3, Webcast, Surgeon, ATEC, RSVP, Premier Health Partners, Dentistry, S1

The Company will introduce the Calibrate LTXTM lateral expandable implant system, technology designed to better achieve alignment goals with precise lordosis control and disc height restoration.

Key Points: 
  • The Company will introduce the Calibrate LTXTM lateral expandable implant system, technology designed to better achieve alignment goals with precise lordosis control and disc height restoration.
  • “ATEC is uniquely dedicated to improving lateral surgery,” said Pat Miles, Chairman and Chief Executive Officer.
  • “The release of Calibrate LTX elevates our lateral procedural thesis by better enabling surgeons to achieve the most elusive goal of surgery: alignment.
  • Our path to becoming the standard bearer in lateral surgery will be apparent.”
    Anthony Kwon, M.D., Orthopedic Spine Surgeon at OrthoCarolina and Atrium Medical Center in Charlotte, NC, added, "The Calibrate LTX expandable lateral system seamlessly integrates with ATEC's entire lateral platform.

4WEB Medical Receives 510k Clearance to Market New Integrated Cervical Plate

Retrieved on: 
Wednesday, September 27, 2023
Momentum, Medicine, Most, Research and development, Development, CSTS, Growth, Xenco Medical, Lordosis, Birth control, Fine chemical, DALLAS, Q3, Research

DALLAS, Sept. 27, 2023 /PRNewswire/ -- 4WEB Medical, an orthopedic implant company focused on developing innovative implants that utilize its proprietary Truss Implant Technology™, announced that it has received 510K clearance to market the newest additions to the company's implant portfolio, the Cervical Spine Truss System (CSTS) Integrated Plating Solution and two cervical interbody line extensions which include implants with 12 degrees of lordosis and an option for a large footprint (16mm x19mm).

Key Points: 
  • Jonathan Hires, Director of Research and Development commented, "The CSTS Integrated Plating Solution provides an additional stand-alone treatment option for 4WEB's surgeon customers.
  • With two product launches in Q3 and regulatory clearance for the integrated plate, we have built significant momentum towards completing the company's comprehensive cervical portfolio by the end of the year."
  • The CSTS Integrated Plating Solution clearance follows several recent milestones including the launch of a non-integrated cervical plating solution and a second-generation cervical interbody fusion device which came to market in Q3.
  • With this portfolio expansion and continued product development, 4WEB has established itself as a leader in the cervical interbody fusion market.

Aurora Spine Announces Presentation on DEXA Technology at the American Association of Neurological Surgeons Annual Meeting

Retrieved on: 
Wednesday, April 12, 2023
Aurora, ASG, Elastic modulus, 3D, Titanium, Subsidence, Research, Los Angeles Convention Center, Science, American Association of Neurological Surgeons, AANS, Patient, PEEK, Lordosis, DEXA, Birth control

Carlsbad, California, April 12, 2023 (GLOBE NEWSWIRE) --

Key Points: 
  • Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced that its DEXA Technology will be highlighted at a presentation delivered by Dr. Sebastian Koga, neurosurgeon at Forrest Health Institute of Neuroscience, at the 2023 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting.
  • The meeting will be held on April 21-24, 2023, at the Los Angeles Convention Center.
  • Dr. Koga’s presentation titled ‘Comparative Subsidence Analysis Between 3D Printed Bone Density Matched Titanium and PEEK Cervical Interbody Fusion Devices’ will be delivered on Sunday, April 23rd at 2pm.
  • Dr. Koga’s presentation will discuss subsidence, which occurs when the vertebral disc experiences cavitating or sinking around an implant.

EMPIRICAL SPINE COMPLETES FULL PREMARKET APPROVAL (PMA) SUBMISSION TO FDA FOR LIMIFLEX™ DYNAMIC SAGITTAL TETHER™

Retrieved on: 
Monday, December 19, 2022
Tether, Quality of life, DST, Surgeon, NASS, Lordosis, Patient, SAN, IDE, Learning, Hospital, FDA, Clinical trial, Laminectomy, Spondylolisthesis, CNS, PMA, Spine, Principal, Decompression, Investigational device exemption, Motion, Standard of care, Spinal stenosis, University of Pennsylvania Health System, Pharmaceutical industry, Medical device, Bookbinding

SAN CARLOS, Calif., Dec. 19, 2022 /PRNewswire/ -- Empirical Spine, Inc., a medical device company creating a new class of spinal implant, recently completed the final step in the U.S. Food & Drug Administration (FDA) submission process for the LimiFlex™ Dynamic Sagittal Tether™ (DST). The Premarket Approval (PMA) submission included Module III, with data and analysis of the two-year results from the pivotal Investigational Device Exemption (IDE) clinical trial comparing LimiFlex DST stabilization versus fusion surgery for degenerative spondylolisthesis (degen spondy) patients with spinal stenosis.

Key Points: 
  • The device previously received the FDA's Breakthrough Designation for its potential to provide significant advantages over currently approved spinal stabilization technologies.
  • The LimiFlex DST uses a completely different concept than past devices to provide durable symptom resolution while preserving spinal motion.
  • Completing the entire PMA submission is an important milestone in the commercial approval process for LimiFlex DST.
  • Caution: The LimiFlex Dynamic Sagittal Tether is an investigational device in the United States and is limited by law to investigational use.

ChoiceSpine™ Announces Line Extension of their Harrier™ Stand-Alone Anterior Lumbar Interbody Fusion System

Retrieved on: 
Tuesday, November 22, 2022
Health, Surgery, Other Health, Medical Devices, Harrier, Growth, Investment, Stryker Corporation, Physician, 3D, Lordosis, Satellite navigation device

ChoiceSpine LLC, a privately-held spinal device manufacturer based in Knoxville, TN, announces the launch of an additional lordotic offering for their stand-alone anterior lumbar interbody Harrier SA.

Key Points: 
  • ChoiceSpine LLC, a privately-held spinal device manufacturer based in Knoxville, TN, announces the launch of an additional lordotic offering for their stand-alone anterior lumbar interbody Harrier SA.
  • View the full release here: https://www.businesswire.com/news/home/20221122005584/en/
    Harrier SA is a 3D printed stand-alone screw-based system incorporating ChoiceSpine's proprietary BioBond porous structure technology.
  • The Harrier SA System now provides further flexibility to the surgeon community to address different patient anatomies.
  • The Harrier SA Anterior Lumbar Interbody System includes:
    Three Lordotic options for each footprint: 10, 15, and 20
    ChoiceSpine LLC is a spinal device company located in Knoxville, TN, privately held by Altus Capital Partners.

ATEC Launches Expandable Technology for Medialized Posterior Procedure

Retrieved on: 
Wednesday, October 12, 2022
Biotechnology, Health, Surgery, Medical Devices, EOS, Bleeding, ATEC, Decompression, Lordosis, Nasdaq, Technology, Goal, PSX, Company, Disease, CEO, Orthopedic surgery, MIS, Standard-bearer, The Standard Bearer, Dentistry, Spine

Alphatec Holdings, Inc. (Nasdaq: ATEC), a provider of innovative solutions dedicated to revolutionizing the approach to spine surgery, announced that at the 2022 NASS Annual Meeting , the Company will introduce expandable interbody and access technology designed to enhance the medialized minimally-invasive (MIS) posterior approach.

Key Points: 
  • Alphatec Holdings, Inc. (Nasdaq: ATEC), a provider of innovative solutions dedicated to revolutionizing the approach to spine surgery, announced that at the 2022 NASS Annual Meeting , the Company will introduce expandable interbody and access technology designed to enhance the medialized minimally-invasive (MIS) posterior approach.
  • The procedure is designed to minimize muscle morbidity and blood loss, which enables shorter hospital stays and faster patient recoveries.
  • The ATEC MIS medialized approach integrates elegant access and expandable implant technology with ATECs InVictus Fixation System.
  • ATEC has significantly improved the approach by integrating specifically designed technology to enable simple and elegant interbody placement.

Accelus Announces New Milestone with Its FlareHawk® Interbody Fusion System Surpassing 15,000 Devices Implanted

Retrieved on: 
Tuesday, October 11, 2022
Adoption, Porosity, Nerve injury, Transverse plane, Robotics, Population, Part, PALM, Patient, Lordosis, Entrepreneurship, INT, Technology, Instrumented posterior lumbar interbody fusion, Certification, Spine, BEACH, PMID, MIS, GLOBE, CE, FDA, Medical device, Trapping, Safety

The increased surface area after expansion and its large anterior column structural support help facilitate fusion.

Key Points: 
  • The increased surface area after expansion and its large anterior column structural support help facilitate fusion.
  • The FlareHawk portfolio of expandable lumbar fusion devices includes FlareHawk9, FlareHawk7 and the titanium-coated TiHawk7, TiHawk9 and TiHawk11 cages.
  • FlareHawk cages all feature Acceluss innovative Adaptive Geometry, which allows the devices to be inserted with a minimal insertion profile before expanding in width, height and lordosis.
  • Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance.

LIMIFLEX™ IDE CLINICAL TRIAL INVESTIGATOR TO PRESENT POSITIVE FINDINGS AT THE NORTH AMERICAN SPINE SOCIETY ANNUAL MEETING

Retrieved on: 
Thursday, October 6, 2022
Tether, Quality of life, Spinal stenosis, SAN, Upstate University Hospital, Significance, Decompression, PMA, Population, US Foods, Patient, Spondylolisthesis, ADL, Research, Lordosis, NASS, Laminectomy, North American Spine Society, Spine, Disability, Orthopedic surgery, MD, Motion, ODI, Disease, CEO, Safety, Clinical trial, Sciatica, DST, Annual general meeting, FDA, IDE, Surgeon, Premarket tobacco application, Medical device, Bookbinding, Vaccine, Medical imaging

"These data indicate that LimiFlex DST is a promising alternative to fusion for this large patient population."

Key Points: 
  • "These data indicate that LimiFlex DST is a promising alternative to fusion for this large patient population."
  • The LimiFlex DST is the only device designed to restore the natural flexion stability of the lumbar spine.
  • The company is currently concluding a pivotal IDE trial in the U.S. For more information: https://www.limiflex.com/ .
  • Caution:The LimiFlex Dynamic Sagittal Tether is an investigational device in the United States and is limited by law to investigational use.