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Certified Superior Interspinous Spacer PMA No. P140004Executive SummaryThis Executive Summary presents an abstract of the clinical trial conducted to support FDA approval of the Certified Superior

How to fill out vertiflex superion interspinous spacer

How to fill out vertiflex superion interspinous spacer:

1. Begin by preparing the patient for the procedure according to standard surgical protocols. This may include preoperative evaluation, anesthesia administration, and appropriate positioning of the patient.
2. After ensuring proper patient preparation, access the surgical site by making a small incision over the targeted interspinous space using a minimally invasive technique.
3. Identify the appropriate level for the placement of the vertiflex superion interspinous spacer. This is usually determined based on diagnostic imaging studies and clinical evaluation of the patient's condition.
4. Carefully insert the spacer into the targeted interspinous space using specialized surgical instruments. The spacer should be positioned between the spinous processes to provide the desired therapeutic effect.
5. Once the spacer is positioned correctly, secure it in place using the recommended fixation mechanisms provided by the manufacturer. This may involve the use of screws, anchors, or other devices based on the specific design of the vertiflex superion interspinous spacer.
6. Confirm the proper placement and fixation of the spacer using fluoroscopy or other imaging techniques. This allows for real-time visualization and adjustment if necessary.
7. After confirming the successful placement, close the incision site using appropriate sutures or wound closure techniques.
8. Postoperatively, provide the patient with necessary instructions for recovery, including physical therapy, pain management, and follow-up visits to monitor the effectiveness of the vertiflex superion interspinous spacer.

Who needs vertiflex superion interspinous spacer:

1. Patients with symptomatic lumbar spinal stenosis: This condition often causes compression of the spinal nerves, leading to symptoms such as lower back pain, leg pain, and difficulty walking. The vertiflex superion interspinous spacer can help relieve these symptoms and improve the patient's overall function.
2. Individuals who have not responded to conservative treatments: When conservative treatments such as physical therapy, medications, and epidural injections have been unsuccessful in managing the symptoms of lumbar spinal stenosis, the use of an interspinous spacer like the vertiflex superion can be considered as an alternative treatment option.
3. Candidates with appropriate anatomical characteristics: Not all patients are suitable for the vertiflex superion interspinous spacer. Proper patient selection based on the individual's anatomy, spinal condition, and clinical presentation is crucial to ensure successful outcomes and minimize potential complications. This decision should be made by a qualified healthcare professional, such as a spine surgeon or interventional pain specialist, after a comprehensive evaluation and discussion with the patient.

For pdfFiller’s FAQs

What is vertiflex superion interspinous spacer?

The Vertiflex Superion Interspinous Spacer is a medical device used in the treatment of lumbar spinal stenosis.

Who is required to file vertiflex superion interspinous spacer?

Healthcare providers and facilities are required to file reports on the use of the Vertiflex Superion Interspinous Spacer.

How to fill out vertiflex superion interspinous spacer?

The Vertiflex Superion Interspinous Spacer report should include detailed information on the patient, procedure, and outcomes.

What is the purpose of vertiflex superion interspinous spacer?

The purpose of the Vertiflex Superion Interspinous Spacer is to relieve symptoms of lumbar spinal stenosis and improve quality of life.

What information must be reported on vertiflex superion interspinous spacer?

The report should include patient demographics, procedure details, outcomes, and any adverse events.

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