Centinel Spine received a green signal for its devices

Image Credit: Orthostreams

Announcement 

The Centinel Spine, LLC, the popular medical device company targeting treatment of lumbar spinal disease and cervical, with clinically proven and the completion of total disc replacement (TDR) technology platform under prodisc®, proudly confirmed its US Food and Drug Administration (FDA) premarket approval (PMA) for two-stage indications. The two-stage indications for the prodisc C SK and prodiscC vivo cervical TDR devices. The approval for the first-stage indications from the FDA was received in July 2022. With this progress, around 20,000 prodisc C SK and prodiscC vivo spinal stage have been utilised in the US by over 1,100 surgeons.

Prodisc devices' excellence journey

Around 480 participants were enrolled in the IDE clinical study from 31 centres, and 433 participants. PMA is calculated based on analysis. By far, this is the vast number of subjects used to contribute to a PMA for any cervical TDR device to achieve in the market. The clinical study was the I nitila attempt to examine the primary PMA-based and two investigational TDR devices on an IDE clinical study that measures an investigational system to an approved PMA cervical TDR device.

Healthcare leaders’ statement

The MD, Orthopaedic spine surgeon at the disc replacement centre in Salt Lake City, UT, Armen Khachatryan, said, “It’s a big day for cervical arthroplasty. I am excited to experience the blend of our initiative in the prodiscC SK and prodiscC vivo clinical trial for a two-stage indication showed up as the FDA approval. I am thrilled about unifying the individual configurations of the prodisc devices in my clinical practice. This approval extended the numerous treatment alternatives accessible to patients and states the consistency and refinement of motion serving surgical techniques mainly for cervical spine disorders.”

The orthopaedic spine surgeon with Michigan Orthopaedic Surgeons, MI, Southfield, Dr Jad Khalil, said, “The cervical disc arthroplasty is a superior option to the traditional blended surgery. The various clinical trials have resulted in brilliant outcomes, and our research group was lucky to be a part of this excellent clinical trial on the future generation of prodisc cervical devices for two-stage arthroplasty. The prodiscC SK and prodiscC vivo system is different due to its potential to match and complement the implant of the patient's anatomy for a clear idea of the procedure. We are thrilled to witness the release of the extended indications for this system.”