lumbar surgery News
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SurGenTec® Announces First-of-its-Kind FDA Clearance for its 3D GraftRasp System™ Including Key Spine Indications
The 3D GraftRasp System is the only device to receive FDA clearance that allows for both decortication of bone and the delivery of autograft, allograft or synthetic bone graft. It is approved for general orthopedic use and spine procedures. “In spine procedures, the transverse processes and facet joints may now be targeted in a more efficient and effective surgical technique pioneered by ...
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Cerapedics Announces Results from Clinical Trial of i-FACTOR Peptide Enhanced Bone Graft in Lumbar Fusion Surgery
Cerapedics, a private ortho-biologics company, today announced that results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery has been published in the May 2020, Volume 20, Issue 5 print of The Spine Journal as the lead article. The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft plus local bone had a ...
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Pinnacle Spine Group Announces Launch of InFill V2 Lateral Interbody Device for Lumbar Spinal Fusion Surgeries
Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions engineered to deliver optimal bone graft volume and graft-to-endplate contact, today announced the launch of its InFill® V2 Lateral Interbody Device. The innovative InFill V2 Lateral Interbody Fusion device features a larger, single graft chamber and a large load-bearing surface area, which helps restore and maintain ...
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Cerapedics Completes Enrollment of Pivotal U.S. FDA IDE Study for its P-15L Bone Graft
Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, announced today the completion of enrollment of the ASPIRE study, a pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study, to evaluate the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion (TLIF) surgery in patients with ...
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DiscGenics Announces Completion of Enrollment in U.S. Phase 1/2 Clinical Trial of Discogenic Cell Therapy for Degenerative Disc Disease
DiscGenics, Inc., a clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that it has completed enrollment in its Phase 1/2 first-in-human U.S. clinical study of IDCT, an allogeneic, injectable Discogenic Cell therapy for degenerative disc ...
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Cerapedics Announces FDA approval of an IDE supplement
Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the on-going clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF) surgery. “We are pleased to announce ...
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Wenzel Spine Announces Publication of Case Series Detailing Endoscopic Transforaminal Decompression and Fusion Technique with VariLift-LX
Wenzel Spine, Inc., a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders, today announced a 24 Consecutive Patient Case Series detailing an endoscopic, stand-alone TLIF surgical technique used with the VariLift-LX System has been published in the Journal of Spine, Volume 7, Issue 2. The Case Series, authored by Kai-Uwe ...
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Wenzel Spine Announces Commercial Launch of the VariLift-LX
Wenzel Spine, Inc., a pioneer medical device company focused on providing minimally invasive, expandable stand-alone alternatives to traditional spinal fusion, announced today the full commercial availability of the VariLift-LX System throughout the U.S. VariLift®-LX represents the next generation of Wenzel Spine’s innovative product lines of Expandable Stand-Alone interbody fusion ...
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DiscGenics Announces Presentation of Positive Interim Clinical Data from Phase 1/2 Study of Cell Therapy for Degenerative Disc Disease
Allogeneic discogenic cell therapy was well tolerated and produced clinically meaningful, statistically significant improvements in low back pain, function, and quality of life by 12 weeks following intradiscal injection; improvements were sustained at the one-year interim readout with additional data to follow at 18 and 24 months. Salt Lake City, UT – February 25, 2022 – ...
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Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex™ Paraspinous Tension Band, today announced initiation of the PMA process for FDA review and approval of the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The Pivotal Trial supporting the PMA compares outcomes of patients who receive either LimiFlex or ...
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Empirical Spine Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in the investigational arm of its U.S. IDE trial studying the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal ...
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Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in its U.S. IDE trial studying the use of LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) ...
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