Applications

1605 – Transcatheter delivery of a dual-filter cerebral embolic protection system during transcatheter aortic valve implantation

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Complete
  • Type New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Supported

Application details

Reason for application

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Service or technology in this application

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.

Type: Therapeutic

Medical condition this application addresses

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.

Meetings to consider this application

  • PASC meeting: 5 to 6 December 2019
  • ESC meeting: 8 to 9 October 2020
  • MSAC meeting: 26 to 27 November 2020