Keystone Heart, a company based in Caeserea, Israel, won the European CE Mark of approval to bring to market its TriGuard Cerebral Protection Device, a filter designed to prevent the entry of emboli into the vasculature leading up to the brain when performing transcatheter aortic valve replacement (TAVR) procedures.
Strokes are a serious cause for concern when placing prosthetic heart valves through minimally invasive techniques because a good deal of calcified material stuck to the walls around the native valve can get dislodged. The TriGuard device is delivered via the same access ports as the instruments used for TAVR, and positioned to cover the three aortic cerebral branches leading up to the brain. Once the valve is placed, the TriGuard is removed and the patient is ready for recovery.
From the product page:
- Nitinol® mesh designed to deflect embolic debris
- Nitinol® flexible wire Frame.
- 9 French compatible retrievable device
- Protects entire cerebro-vascular system
- Eliminates need for third access site during TAVI
- Rapidly deploys and self-positions