West Chester, PA – Tuesday, June twenty first, 2022 /OrthoSpineNews/ – Altus Backbone, a pacesetter within the improvement and innovation of medical units utilized in spinal correction surgical procedure, declares FDA 510(Okay) clearance of Sochi OCT System.
The Altus Backbone Sochi OCT System gives a seamless transition from occiput to sacrum. The Sochi OCT System is comprised of polyaxial screws, hooks, rods, locking screw assemblies and connectors which can be rigidly locked collectively in quite a lot of configurations to advertise fusion for all kinds of affected person anatomies.
“To adapt to all kinds of affected person anatomies, whereas additionally accommodating surgeon desire, our group designed a system that may be configured in a number of completely different variations.” mentioned Michael Fitzgerald, President and CEO.
The FDA’s motion signifies that The Sochi OCT Spinal System is indicated to advertise fusion of the occipito-cervico-thoracic areas of the backbone (Occiput – T3). The meant indications are as follows: Degenerative Disc Illness (as recognized by neck or again ache of discogenic origin with degeneration of the disc confirmed by historical past and radiographic research), Spondylolisthesis, Spinal Stenosis, Fracture/Dislocation, Deformities or Curvature, Tumors, Pseudarthrosis, Atlanto/axial fracture with instability, Occipitocervical dislocation, and Revision of earlier cervical and higher thoracic backbone surgical procedure. The hooks and rods are additionally meant to supply stabilization to advertise fusion following discount of fracture/dislocation or trauma within the cervical/higher thoracic (C1-T3) backbone.
The Altus Backbone Sochi OCT Spinal System can be linked to the Monaco Pedicle Screw System with the usage of transition rods and rod connectors.
“This FDA clearance is a good addition to our various portfolio of merchandise. Its potential to configure and regulate to all kinds of sufferers is a design facet that may be very helpful within the discipline,” mentioned Fitzgerald, “As we proceed advancing our portfolio by creating progressive merchandise and applied sciences, our main purpose is offering higher outcomes for our sufferers whereas fixing issues surgeons face within the OR.”
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Based mostly in West Chester, PA, Altus Backbone is devoted to creating the following era of medical units. Altus strives to enhance affected person care by designing and manufacturing merchandise to satisfy the best requirements in an ever altering and evolving discipline. Carried out and utilized by over 100 hospitals throughout the US, Altus is among the many quickest rising spinal implant corporations on this planet. For extra info, or to inquire about distribution alternatives, please contact us at email@example.com.
Ahead Trying Statements
All statements made within the above press launch, except for historic reality, could also be forward-looking statements that embrace threat, uncertainty, and assumptions. These components may trigger Altus Backbone’s outcomes to vary from these predicted if they don’t happen as anticipated. These unsure components embrace, however aren’t restricted to: acceptance and clearance of the corporate’s surgical merchandise and procedures, improvement of recent merchandise and procedures, improvements and alterations to current merchandise and procedures, medical and statistical verification of the success utilizing Altus Backbone’s merchandise, firm’s potential to take care of and monitor stock because it releases new merchandise, its potential to rent and retain personnel, and another dangers said in prior or subsequent information releases. All dangers and potential issues may be present in our most up-to-date 510(ok) report from the Food and Drug Administration (FDA). Given the continually altering market, readers are inspired to not place undue reliance on forward-looking statements. Altus Backbone assumes no obligation to replace forward-looking statements as these adjustments happen, or as occasions and circumstances are altered, after the date they’re posted.