Description of Medical ServiceThe 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 ConditionMitral 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 ApplicationNew MBS item
Medical Service TypeTherapeutic technology
Previous Application Number/sRefer to applications 1662 and 1662.1
Application Summary and PICO SetApplication Summary (PDF 237 KB)
Application Summary (Word 46 KB)
PICO Set (PDF 475 KB)
PICO Set (Word 173 KB)
Consultation SurveyConsultation Survey (PDF 165 KB)
Consultation Survey (Word 27 KB)
MSAC consultation input must be received by no later than Friday, 16 February 2024 for it to be considered by MSAC at its April 2024 meeting.
For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process