Overview

The SafeSept® Needle Free Transseptal Guidewire, when used in conjunction with a transseptal dilator and introducer, creates the primary puncture in the interatrial septum, without the need for a transseptal needle.

Transseptal Access without the Transseptal Needle!

Specially designed to replace a transseptal needle while crossing the interatrial septum at the fossa ovalis with improved safety and less force when supported by a transseptal introducer.

The SafeSept® Needle Free Transseptal Guidewire, when used in conjunction with a transseptal dilator and introducer, creates the primary puncture in the interatrial septum, without the need for a transseptal needle, providing access through the septum from the right side of the heart to the left side.

SafeSept NF is a 150cm long, 0.0315 inch diameter nitinol guidewire specifically designed for safer and easier transseptal puncture. The very sharp tip of the SafeSept NF requires less force to perforate and cross the fossa. Unsupported by the dilator and sheath, the tip of the guidewire assumes a ‘J’ shape, rendering it incapable of further tissue penetration.

A radiopaque coil along the shaft allows for fluoroscopic visualisation of the wire within the left atrium while proximal marker bands help determine the approximate location of the SafeSept NF tip in relation to the tip of the dilator. Once proper guidewire location is confirmed, advancement of the transseptal dilator and sheath “over the wire” into the left atrium is accomplished without the use of a transseptal needle.

Turn the stress that accompanies every transseptal stick into a routine, “no hassle” procedure. The SafeSept Needle Free Transseptal Guidewire is part of a complete line of implantable device therapy products and accessories from Pressure Products.

Crossing Tough Atrial Septums

SafeSept helps in 2 ways

  1. The use of SafeSept reduces the force to cross the atrial septum by 77%[1]
  2. By “parking” the tip of the SafeSept 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.

[1]average reduction

Reducing the Procedural Complication Rate

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.

SafeSept NF is a simpler and safer alternative to the RF Transseptal Needle.

Product datasheet