Yes, Medicare and Medicaid cover the cost of treatment for Vertiflex spinal stenosis. Other commercial insurance firms also cover it. Check with your insurance company to see if Vertiflex is covered under your policy.
How long does Vertiflex last?
The implant works by releasing pressure on the nerves that are damaged. It is a device that is implanted inside the spine and is supposed to help reduce disc space when walking or standing. It expands the room in your spinal columns for your spinal cord and nerves without removing any bone, as a standard laminectomy does. There are a variety of implant sizes available to meet the demands of a wide range of patients. The FDA has approved this implant, which can last up to 5 years. This method is both safe and effective. You will not only be back on your feet in no time, but your range of motion will be preserved.
The recuperation time for the vertiflex is relatively short. Because every patient’s needs are different, it’s critical to carefully follow your doctor’s post-operative instructions. Lifting, bending, and vigorous exercise should be avoided for 6 weeks after your Vertiflex operation. You can increase your light activity and enjoy things like walking or light exercise at this time. You should expect some stiffness following the treatment, and the incision through which the implant was inserted will have a few sutures that should be maintained clean.
LSS can deteriorate over time if left untreated, leading to an abnormal narrowing of the spinal canal. This can cause further pain and suffering, as well as limited movement, by constricting the nerves in the spine that flow down into the legs. If you have back discomfort, consult your doctor to discover if Vertiflex is a viable therapy option.
Is Vertiflex covered by Medicare?
The Centers for Medicare & Medicaid Services has approved funding for VertiFlex’s Totalis direct decompression device for the treatment of spinal stenosis.
VertiFlex, situated in San Clemente, California, develops minimally invasive devices to treat lumbar spine stenosis, which is a primary cause of spinal surgery in the elderly. The Totalis direct decompression system consists of a collection of minimally invasive surgical equipment for lumbar spine decompression. The FDA approved the device in November 2012.
Totalis will be offered to patients who are engaged in an approved clinical study under the terms of the coverage, which includes reimbursement for approved clinical trial patients.
“We are quite thrilled with CMS’ decision to enable CED for this exciting technology.” For Medicare beneficiaries, there is now a reimbursement pathway for PILD treatments and Totalis. In prepared remarks, CMS president and CEO Earl Fender said, “We appreciate CMS’ leadership in allowing Coverage with Evidence Development, and we look forward to collaborating with them to establish a robust clinical trial design.”
Last year, VertiFlex sold its spinal implant technology to Stryker (NYSE:SYK), claiming that the technology was not critical to the company’s core business.
Who is not a candidate for Vertiflex?
If you have or have had the Vertiflex Procedure, you are not a candidate.
- Cauda equina syndrome is a condition that affects horses (when the nerve roots in your low back are severely compressed, which can permanently affect your movement and sensation)
- Greater than grade 1.0 spondylolisthesis or degenerative spondylolisthesis (on a scale of 1-4)
- More than 2.5 S.D. of severe osteoporosis in the spine or hip (DEXA scan or similar).
- An ongoing systemic infection or a localized infection at the implantation site
Who is a candidate for Vertiflex?
A successful Vertiflex interspinous Spacer at L2-3 was performed by Dr. Daniel Roshan, a Pacific Pain Physician. The patient had right side dominant low back and leg discomfort due to a narrowing of the spinal and nerve canal at the L2-3 level. Walking made his pain worse, and sitting and sleeping made it better, as is characteristic with spinal stenosis and neurogenic claudication symptoms. He had gotten good relief with lumbar epidural steroid injections in the past, but the effects faded off faster as time went on. Because the patient wished to avoid back surgery and sought a long-term solution, the decision was taken to implant a vertiflex spacer at L2-3. The treatment took less than an hour to perform, and the patient was able to return home the same day. He has gotten 75% relief from his right leg and low back pain so far!
This is a narrowing of the spinal canal caused by degradation of the spine’s discs and the proliferation of arthritic joints as we become older. This can exert pressure on the spinal cord, causing leg pain, cramping, and even weakness in the patient. Standing or walking usually aggravates this, while sitting, laying down, or bending forward slightly improves it. Walking and standing aggravates the discomfort because it causes the spinal canal to narrow more than while bending forward or sitting. Due to the agony, people with stenosis can sometimes only walk half a block or less before needing to sit down.
In the field of pain management, a series of epidural steroid injections is commonly used to assist relieve discomfort and enhance functionality. However, you should only do a few of these per year because they don’t always stay long enough or start to wear off faster as the stenosis progresses. Patients would then be referred to a spine surgeon for surgery to decompress the level of the spine. However, due to old age and other medical issues, some individuals are not excellent surgical candidates. Some patients would rather avoid surgery if at all possible.
It is a small metallic device that is inserted between two adjacent bone segments of the spine where there is stenosis. It is MRI compatible.
It works by acting as a door stop to prevent further narrowing of the canal when you walk and stand, resulting in less pain and increased capacity to stand and move for the patient.
It’s done with a set of tools through a small incision in your back to get access to the area, measure the patient’s particular space at that level, and then implant the device between the surrounding vertebral bones.
A patient with 1-2 level lumbar stenosis who has failed conservative management/epidural steroid injections and is not a surgical candidate or does not want to undergo surgery.
During the vertiflex procedure, no bone is sliced or removed. In fact, if you need surgery, your spine surgeon will find it rather simple to remove it.
Make an appointment with one of our four double board certified pain experts, Drs. Hullander, Mozingo, Pires, and Roshan, if you have any further questions!
What is the success rate of Vertiflex?
For the right patient, the Vertiflex Procedure is beneficial. The IDE trial, which was the largest FDA Lumbar Spinal Stenosis Device Trial Ever Conducted and tracked patients for up to 5 years, was the first to look into this therapeutic option. Data from patients who reported positive outcomes back up this level-one evidence-based technique. At the 5-year mark, the investigation revealed the following findings:
Another study published in November 2018 in the Journal Pain Research found an 85 percent reduction in opioid use after five years.
In the end, the Vertiflex surgery is changing the way patients are treated for LSS. It offers patients a minimally invasive, clinically validated remedy for leg and back pain caused by Lumbar Spinal Stenosis. The outcomes and recovery of each patient are always unique and specific. The Vertiflex treatment is one of the few with a five-year track record.
Is VertiFlex a PILD?
The Centers for Medicare & Medicaid Services (CMS) has announced that VertiFlex Inc.’s spinal stenosis therapy technique will now be reimbursed. CMS has made a final decision on Percutaneous Image Guided Lumbar Decompression (PILD) for spinal stenosis, enabling coverage while evidence is being developed (CED).
Is VertiFlex FDA approved?
The Superion Interspinous Spacer System from VertiFlex has received PMA approval to treat spinal stenosis. Patients with moderate lumbar spinal stenosis can use the device.
Is Vertiflex an outpatient procedure?
Vertiflex is an outpatient surgery that involves a small incision and a local anesthesia. We utilize a thin tube, commonly known as a dilator, to shift the tissue and create a channel for placing a small titanium alloy implant called SuperionTM rather than cutting through it.
Is Vertiflex procedure painful?
When you get your Vertiflex Bux implanted, you’ll be put under general anesthesia so you won’t experience any pain. When you’re ready, he makes a very small incision in your lower back and uses fluoroscopy (live X-ray) to guide him as he inserts a metal tube between your vertebrae.