Application Detail

Description of Medical Service

Percutaneous trans-radial delivery of a dual-filter cerebral embolic protection (CEP) system, designed to capture and remove debris that may enter the cerebral vascular system during the transcatheter aortic valve implantation (TAVI) procedure. The CEP system is comprised of two independent deployable filters, with sizes suitable for the arteries that provide the main blood supply to the brain. The CEP system is inserted via the radial artery, delivering an intra-luminal filter in the common trunk of the branchiocephalic artery (proximal filter), with a second filter delivered in the proximal section of the left common carotid artery (distal filter), filtering approximately 90% of the blood flow to the brain. At completion of the procedure, the filters and any captured debris are retrieved into the catheter and removed from the patient.

Description of Medical Condition

Embolic ischaemic strokes can occur in patients undergoing endovascular procedures. The origin of these embolic cerebrovascular events is variable and can include dislodged calcium particles, atherosclerotic plaque material, thrombus, valve and arterial wall tissue, and sheared interventional catheter coating material. When the embolic material (thrombus/debris) lodges in an artery and blocks the flow of blood, this leads to a type of ischaemic stroke. This is a serious event that can lead to serious debilitation or death.

Many endovascular procedures associated with structural interventions are known to be cardioembolic, including transcatheter aortic valve implantation/replacement, mitral valve repair/replacement, left atrial appendage closure, valve in valve, and thoracic endovascular aortic repair. Given that the largest body of clinical evidence is from studies conducted in patients with severe, symptomatic aortic stenosis undergoing TAVI, this application focuses on the use of the percutaneous trans-radial delivery of a dual-filter CEP system as an adjunctive therapy for TAVI.

Reason for Application

-

Medical Service Type

Therapeutic

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1584 KB)
Application Form (Word 1093 KB)

Consultation Survey

Consultation Survey (PDF 487 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

PICO Confirmation (PDF 1723 KB)
PICO Confirmation (Word 733 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 696 KB)
Public Summary Document (Word 174 KB)

Meetings for this Application

PASC

5-6 December 2019

ESC

8-9 October 2020

MSAC

26-27 November 2020