Vertiflex-Inter-Spinus Spacer Implant

What Is The Vertiflex Procedure Or Inter-spinus Spacer Implant (ISSI)

An ISSI is an “H” shaped, titanium implant inserted between the spinous process (the boney projections off each vertebra). ISSIP is indicated for patients who have leg/buttock/groin pain, numbness, and/or cramping, with or without back pain when standing or walking, which is relieved when they bend forward or sit. You must undergo at least six months of conservative non-operative treatment before having this procedure. The Vertiflex Procedure or ISSI is intended to provide the same relief you experience when leaning forward or sitting down. It fits your pain by reducing or eliminating the pressure on the nerves caused by Lumbar Spinal Stenosis (LSS). The spacer is also available in several different sizes to fit your anatomy.

Who is a Candidate?

Patients diagnosed with LSS, who have difficulty standing for long periods of time, walking any distance without assistance and pain in their low back / legs, who have failed or no longer get relief from spinal injections.

How does the Vertiflex Procedure work?

The Vertiflex Procedure is a safe, minimally invasive treatment that has been clinically proven to provide effective long-term relief from the pain associated with LSS.

• FDA approved
• Same-day procedure. The procedure can be completed in an outpatient setting and most patients can return home within the same day
• Quick recovery time
• Usually covered by Medicare and several private insurance companies, based on medical necessity (Each insurance company and patient’s plan will vary).

Placement

You will be put to sleep with a medication given through an IV (tube) in your arm and you will breathe on your own This is known as Monitored Anesthesia Care (MAC). A trained anesthesia clinician will monitor you continually while you are asleep. A small incision is made to gain access to the affected space. The appropriately sized implant is delivered through a small metal tube. Live X-rays called fluoroscopy are taken to confirm the correct placement of the implant.

Activation

Once inserted, the spacer’s arms open around the spinous processes (the bumps you can feel in your spine) to help make proper space for the affected nerves. The small metal tube is removed, the incision is then closed with sutures or staples.

Relief

The spacer preserves the space in the spine, which keeps pressure off the nerves that cause leg and back pain.

How effective is it?

The Vertiflex Procedure was the subject of an extremely thorough FDA clinical trial for LSS. Results from the trial proved the effectiveness of the procedure, with significant improvement in pain relief, overall results may vary.