How long does Coflex implant last?
Our retrospective study has demonstrated that the interlaminar-interspinous implant provides long-term pain relief at 2- and 5-year follow-up for patients with low-back pain and leg pain.
Is Coflex surgery painful?
In almost all cases, your pain will be significantly relieved, because the cause of the stenosis will have been surgically remedied. Some patients do experience some pain at the site of the incision, but this usually subsides considerably in the days and weeks following surgery.
What can I expect after Coflex surgery?
Most patients are able to return to normal activity, and even expanded activity such as golf, cycling, gardening and other activities, within weeks of the surgery. Some patients may require physical therapy to help with mobility and flexibility°. Every patient is different; therefore results may vary.
How long does Coflex surgery take?
The Surgical Procedure The Coflex device is positioned on your lamina, which is the strongest bone in the back of your spine. On average, the entire procedure, including decompression and the implantation of the Coflex device, takes approximately 100 minutes.
Is Coflex safe?
For patients receiving the Coflex device, the biggest risk is continued pain. Other risks include wound healing problems (such as infection or drainage), brief numbness or tingling in your arms or legs, and spinous process fractures. In the clinical trial, similar problems were experienced with patients who had fusion.
Can Coflex be removed?
* Do not use the trial to remove the coflex® device. Such use may result in damage to the coflex®, the trial, or both. * Use only the surgical pliers provided in the coflex@ instrument set to adjust the wings of the device. Use of other instruments may lead to wing damage or breakage.
How long is recovery from Coflex surgery?
Coflex surgery requires about 4 to 6 weeks for a complete recovery.
Is Coflex FDA approved?
FDA approves Paradigm Spine’s cost-saving Coflex spinal stenosis treatment. Paradigm Spine won FDA approval for its Coflex spinal stenosis treatment system, the 1st such device to treat moderate to severe cases of spinal stenosis that may present with or without back pain.
Does Medicare cover Coflex surgery?
Coverage Guidance from Surgalign Surgalign is focused on expanding patient access to the Coflex® technology. Coverage includes Medicare and no prior authorization is required for Parts A and B. Our CS team has extensive experience supporting offices through the insurance coverage process for the coflex procedure.
What is Coflex Stabilisation?
Coflex® is a small, slightly flexible titanium implant device implanted following a minimally-invasive lumbar decompression to stabilize the lamina while preserving some motion. The lamina is the back portion of the arch that forms the roof of the spinal canal that covers the spinal nerves.
How long after mild procedure do you see improvement?
Some patients see improvement within 72 hours after the procedure, but most will see improvement within a few weeks of the procedure.
What is Coflex made of?
The COFLEX® device consists of a single, U-shaped component, made from medical-grade titanium alloy, a material with a long history of safe use in implantable orthopedic products.
What is a coflex implant?
The coflex is an implant that is surgically placed during a minimally invasive procedure. The device is designed to provide a greater range of motion than what’s often experienced following traditional fusion surgery. Patients with the coflex are often able to: *According to comparison studies of both procedures.
Are You a candidate for a coflex implant?
Ultimately, determining if you are a candidate for a coflex implant involves: There is some risk with any spine surgery, even with a minimally invasive procedure. In trial studies, some patients did experience brief numbness, issues with wound healing, and problems related to preexisting medical conditions.
Is additional coflex implantation safe and beneficial in symptomatic LSS?
Previous research reported that additional Coflex implantation was safe but not beneficial in the treatment of symptomatic LSS [ 25 ]. In the present study, we found significant clinical improvements (JOA, ODI, VAS-back, VAS-leg and SF-36 scores) in patients of both groups after surgery.
Does the implantation of coflex improve lumbar function after cervical fusion surgery?
In the present study, we found significant clinical improvements (JOA, ODI, VAS-back, VAS-leg and SF-36 scores) in patients of both groups after surgery. Although the improvements were not significantly different between the two groups, the implantation of Coflex had the advantage of less trauma, faster recovery and better lumbar function.