Application Detail

Description of Medical Service

A catheter-based technique for the delivery of a permanent implant to the mitral valve via transeptal access. The implant clasps the anterior and posterior leaflets around a spacer, thus creating a double orifice and reducing mitral regurgitation (MR). The Implant System consists of the Steerable Catheter (outermost layer), the Implant Catheter (innermost layer), and the implant. The Implant System percutaneously delivers the implant to the valve via a femoral vein access using a transvenous, transeptal approach. The implant is deployed and secured to the leaflets of the valve, acting as a filler in the regurgitant orifice. The primary components of the Implant are the spacer, paddles, and clasps made from Nitinol. This Application refers to the proposed medical service as transcatheter mitral valve repair.

Description of Medical Condition

MR (also known as mitral insufficiency), is a condition in which incompetency of the mitral valve causes abnormal backflow of blood from the left ventricle to the left atrium during the systolic phase of the cardiac cycle. There are two types of MR: degenerative and functional. Degenerative mitral regurgitation, also known as primary MR, refers to regurgitation resulting from the structural abnormality of the mitral valve leaflets and/or valve apparatus. In contrast, functional mitral regurgitation, also known as secondary MR, occurs when the valve and/or valve apparatus is structurally normal, but dysfunction, distortion, or dilation of the left atrial or ventricular chambers results in tethering of the leaflets and/or mitral annular dilation. MR is associated with an increased risk for heart failure and death

Reason for Application

New MBS item

Medical Service Type

Therapeutic

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1449 KB)
Application Form (Word 378 KB)

Consultation Survey

Consultation Survey (PDF 559 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

-

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 576 KB)
Public Summary Document (Word 146 KB)

Meetings for this Application

PASC

Expedited - Bypassed PASC

ESC

7-8 October 2021

MSAC

25-26 November 2021