Application Detail

Description of Medical Service

Interspinous decompression spacers (IDSs) were designed to treat symptoms of intermittent NIC, secondary to moderate degenerative lumbar spinal stenosis (LSS). They are implanted by minimally-invasive methods. When implanted between spinous processes of symptomatic level(s), IDSs stabilise and increase the interspinous distance and prevent the excessive dorsiflexion. There are a number of IDSs registered for use in Australia, including the device manufactured by the applicant, but some are used in addition to decompression surgery. The applicant’s IDS device is intended for use as an alternative to traditional decompression surgery (most often, laminectomy), with or without surgical fusion. The applicant states the main advantages of an IDS (relative to current approaches) include providing equivalent effectiveness, significantly fewer and less serious risks and complications, and less hospitalisation time (due to the minimally-invasive implantation procedure).

Description of Medical Condition

Lumbar spinal stenosis (LSS) is a disabling medical condition, where narrowing of the spinal canal compresses the spinal cord and nerves, causing a condition called neurogenic intermittent claudication (NIC). NIC can lead to pain or discomfort that radiates to the lower leg, thigh, and/or buttocks while walking. Patients with more pronounced LSS may also develop lower extremity weakness, muscle cramping, numbness, imbalance and difficulties controlling bowel and bladder function. The most common cause of LSS is the 'wear and tear' that occurs with natural ageing and osteoarthritis.

Reason for Application

New MBS item

Medical Service Type

Therapeutic

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1268 KB)
Application Form (Word 122 KB)

Consultation Survey

Consultation Survey (PDF 556 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

PICO Confirmation (PDF 1289 KB)
PICO Confirmation (Word 310 KB)

Assessment Report

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Public Summary Document

Public Summary Document (PDF 815 KB)
Public Summary Document (Word 310 KB)

Meetings for this Application

PASC

15-16 April 2021

ESC

7-8 October 2021

MSAC

25-26 November 2021