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A specially designed guidewire of 135 cm / 0.014" with a flexible J shape sharpened guidewire tip to safety cross the interatrial septum at the fossa ovalis when supported by a transseptal introducer. After penetration, the tip of the wire assumes a 'J' shape, rendering it incapable of further tissue penetration.
Applications:
SafeSept helps in 2 ways
(i) The use of SafeSept reduces the force to cross the atrial septum by 77%*
(ii) By “parking” the tip of the SefeSept wire in one of the left pulmonary veins, prior to attempting to cross with the transeptal needle, the left atrial wall is protected should the needle jump across even when the septum is grossly tented.
The safe crossing position can be determined prior to the large gauge transseptal needle puncture. If the tip of the SafeSept cannot be easily parked in one of the pulmonary veins, the puncture site is probably in the wrong place. The SafeSept wire is then simply withdrawn and the transseptal needle tip repositioned. SafeSept is only 0.014 in diameter, the risk of an adverse event due to an attempted crossing at an incorrect location is very low.
*average reduction
SafeSept is a simpler alternative to the RF Transseptal Needle
Initial clinical experience of SafeSept - Tony Chow
SafeSept estimated to reduce complication rate by more than 80% - Roberto De Ponti
SafeSept reduces septal tenting - Marcus Wieczorek
Use of SafeSept in very elastic or thick septums - Carlo de Asmundis
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