IDE Clinical Study
-
Spine
Premia Spine’s TOPS™ Facet Joint Replacement Demonstrates Significant Improvement in All Patient-Reported Outcome Measures Versus Fusion in FDA Trial
Interim two-year data from clinical IDE trial published in Journal Neurosurgery Spine; lumbar facet arthroplasty moves closer to proving TOPS…
Read More » -
Spine
Premia Spine’s TOPS™ Facet Replacement Demonstrates Significant Improvement in All Patient-Reported Outcome Measures in FDA Trial
One-year data from clinical IDE trial published in Clinical Spine Surgery proves lumbar facet arthroplasty with TOPS device maintains motion…
Read More » -
Spine
Orthofix Announces Presentation of Long-Term Evidence Highlighting the Clinical Management of Cervical Disc Arthroplasty at North American Spine Society Annual Meeting
Data includes results from five-year multi-center IDE study in U.S. of the M6-C disc that also demonstrated strong clinical performance,…
Read More » -
Spine
NuVasive Simplify Cervical Disc Two-level Data Published in Journal of Neurosurgery: Spine
Peer-reviewed results from the two-level multi-center FDA Investigational Device Exemption study reiterate disc’s superiority to ACDF SAN DIEGO, April 21, 2022 /PRNewswire/…
Read More » -
Regulatory
AxioMed Announces Progress with Completing Module I-III Lumbar FDA Submission of The First Lumbar Viscoelastic Disc Replacement to Complete a US IDE Clinical Study
AxioMed presses forward on its FDA submission of documents needed to complete the last Module III of its FDA application…
Read More » -
Spine
AxioMed LLC Files PMA Module II of III targeting 2022 FDA Approval of The First and Only Viscoelastic Lumbar Disc Replacement to Complete an IDE Clinical Study
AxioMed takes another historic step towards achieving FDA approval of its lumbar viscoelastic total disc replacement after submitting PMA Module…
Read More » -
Regulatory
AxioMed LLC Reports Landmark Filing of Initial PMA Module to FDA as the First Viscoelastic Lumbar Artificial Disc Replacement to Complete an IDE Clinical Study
AxioMed seeks to get FDA clearance in 2022 to press its leadership position as the only viscoelastic total disc replacement…
Read More » -
Spine
100th U.S. Patient Treated In IDE Clinical Trials Of Baguera® C Cervical Disc Prosthesis
LAGUNA HILLS, Calif., Nov. 16, 2021 /PRNewswire/ — Spineart USA Inc. announced today that the 100th surgery has been performed in their combined single-level and…
Read More » -
Recon
BioPoly® Granted European Patent for Its Innovative Implant Design
FORT WAYNE, IN – BioPoly LLC has announced that another European patent has been granted for its partial resurfacing implants.…
Read More » -
Extremities
CartiHeal Raises $18.3 Million
KFAR SABA, Israel, May 8, 2017 /PRNewswire/ — Funds will support IDE clinical study for company’s Agili-C™ implant CartiHeal (2009)…
Read More »