Application Detail

Description of Medical Service

The proposed health technology is device-agnostic transcatheter mitral valve repair (TMVr).
Edwards has developed a catheter-based technique for the delivery of a permanent implant to the mitral valve via transseptal access. The implant clasps the anterior and posterior leaflets around a spacer, thus creating a double orifice and reducing MR. The Edwards PASCAL Transcatheter Valve Repair System addresses some of the limitations of other devices, including: a larger implant with wider paddles to potentially reduce the number of implants required for adequate MR reduction; independent clasp control to address complex anatomies and regurgitant jets; a spacer in the centre of the implant to act as a filler in the regurgitant orifice for reduction of MR; working length that allows manoeuvrability even with higher septal puncture heights; and ergonomic controls similar to other Edwards transcatheter product lines which are already familiar to many interventional cardiologists.

Description of Medical Condition

Mitral regurgitation (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 (DMR), also known as primary MR, refers to regurgitation resulting from the structural abnormality of the mitral valve leaflets and/or valve apparatus. Mitral regurgitation (MR) is the most common heart valve disorder worldwide (Dziadzko et al., 2018), with a high prevalence in industrialized nations with aging populations. MR is associated with an increased risk for heart failure and death.

Reason for Application

New MBS item

Medical Service Type

Therapeutic technology

Previous Application Number/s

Refer to applications 1662 and 1662.1

Associated Documentation

Application Summary and PICO Set

Application Summary (PDF 237 KB)
Application Summary (Word 46 KB)

PICO Set (PDF 475 KB)
PICO Set (Word 173 KB)

Consultation Survey

Consultation Survey (PDF 165 KB)
Consultation Survey (Word 27 KB)

PASC Consultation
Not applicable

MSAC Consultation
MSAC consultation input closed Friday, 16 February 2024.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation

-

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 1007 KB)
Public Summary Document (Word 638 KB)

Meetings for this Application

PASC

Expedited - bypassed PASC

ESC

15-16 February 2024

MSAC

4-5 April 2024