DESCRIPTION

SPECIFICATIONS

INFO / VIDEO

CASE STUDIES

Transseptal Access without a Transseptal Needle! The SafeSept Needle Free is 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.

SafeSept® Needle Free Transseptal Guidewire turns the stress that accompanies every transseptal stick into a routine, “no hassles” procedure. 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 easily perforates and crosses 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 visualization 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 need for a transseptal needle.

The all new SafeSept® Needle Free Transseptal Guidewire makes access easier, especially in difficult or even previously failed cases, improving the safety of whatever introducer system you are currently using…  and without the need for a transseptal needle.

Effortless advancement of the SafeSept Needle Free tip perforates the membranous fossa

The transseptal dilator is advanced until it tents the fossa ovalis

The transseptal dilator and introducer sheath are advanced over the SafeSept across the septum

SafeSept Needle Free is slowly advanced into the left atrium

SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE

Model

Length

Diameter

Marker Locations*

SSNF

150cm

67.5cm (|)

0.0315"

75.1cm (||)

84.4cm (|||)

93.4cm (||||)

101.0cm (|||||)

* For most commercially available transseptal introducer systems.

Each SafeSept Needle-free Transseptal Guidewire kit includes:

One transseptal guidewire

One tip straightener

Five (5) kits per box

DOWNLOADS

VIEW INSTRUCTIONAL VIDEO

TRANSSEPTAL ACCESS USING SAFESEPT NEEDLE FREE

Watch entire video including Feature overview and Suggested Procedure.  4:32

VIEW INSTRUCTIONAL VIDEO IN SECTIONS

DEVICE FEATURES

Device description and feature overview.  1:33

TRANSSEPTAL ACCESS:
A SUGGESTED PROCEDURE

Achieving access, positioning and penetration of the fossa ovalis for LA access.  2:01

WARNINGS, INDICATIONS, AND CONTRAINDICATIONS

Important information regarding the SafeSept Needle Free.  1:03

 

Features

Designed to work with all commercially available adult transseptal introducer systems without the need for a transseptal needle

Radiopaque coil allows fluoroscopic visualization of the distal end of the SafeSept NF

Specially designed tip configuration enables effortless penetration of the fossa

‘J’ shape allows safe advancement to assure proper wire location within left atrium

Transseptal introducer and dilator are rendered atraumatic when tracking over the SafeSept Needle Free Transseptal Guidewire

Proximal marker bands help determine transseptal guidewire tip location relative to transseptal dilator tip during the procedure

Comes in 150cm length for compatibility with all currently available adult transseptal introducer systems

SafeSept is a registered trademark of Pressure Products Medical Supplies, Inc.

Patents 8,500,697; 8,292,910; 8,157,829; EP1542593; JP4496223. Other U.S. and worldwide patents pending.

Copyright © 2014 Pressure Products Medical Supplies, Inc. All rights reserved.