DESCRIPTION
SPECIFICATIONS
INFO / PUBLICATIONS
VIDEOS
The very sharp tip of the SafeSept® requires less force than a conventional transseptal needle to cross the interatrial septum, making access easier, especially in difficult or previously failed cases, improving the safety of whatever introducer system you are currently using.
The SafeSept is the first significant advance in left atrial access since the Brockenbrough needle. Specifically designed to cross the interatrial septum at the fossa ovalis when supported by a transseptal introducer, SafeSept is a 135cm long, 0.014 inch diameter nitinol guidewire specifically designed for transseptal puncture.
After the transseptal dilator has “tented” the fossa ovalis, effortless advancement of the SafeSept tip perforates the membranous fossa, requiring less force than a standard transseptal needle. Unsupported by the needle and dilator, the tip of the wire 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 tip in relation to the tip of the needle. The transseptal needle, dilator and sheath are then advanced “over the wire” into the left atrium with virtually no possibility of aortic or pericardial perforation.
Tenting the Interatrial Septum
Advancing SafeSept into the Left Atrium
Needle, Dilator and Introducer Tracking over SafeSept
SafeSept is a registered trademark of Pressure Products Medical Supplies, Inc. Patents 9,821,145; 8,992,556; 8,500,697; 8,292,910; 8,157,829; EP1542593; EP1542593; JP4496223. Other U.S. and worldwide patents pending.
SAFESEPT TRANSSEPTAL GUIDEWIRE
Model
Diameter
Length
SS-135
.014"
135cm
Each SafeSept Transseptal Guidewire kit includes:
One transseptal guidewire
One tip straightener
Five (5) kits per box
DOWNLOADS
PUBLICATION DOWNLOADS
Asmundis C, Chierchia GB, Sarkozy A, et al. “Novel trans-septal approach using a Safe Sept J-shaped guidewire in difficult left atrial access during atrial fibrillation ablation,” Europace (2009) 11 (5):657-659.
Laish-Farkash A, Katz A, Fishman E, et al. “Clinical Experience with Routine Use of SafeSept J-Shaped Guidewire for Transseptal Puncture.” Barzilai Medical Center, Ashkelon, Israel, Cardiology Department, Electrophysiology Unit, Faculty of Health Sciences, Ben Gurion University, Ashkelon, Israel.
Wadehra V, Buxton AE, Antoniadis AP, et al. “The use of a novel nitinol guidewire to facilitate transseptal puncture and left atrial catheterization for catheter ablation procedures,” Europace (2011) 13 (10):1401-1405.
De Ponti R. “Transseptal catheterization for ablation in the left heart: what to do when the door is locked up tight?” Europace (2010) 12 (5):604-605
Wieczorek M, Hoeltgen R, Akin E, et al. “Use of a novel needle wire in patients undergoing transseptal puncture associated with severe septal tenting,” J Interv Card Electrophysiol (2010) Jan; 27(1):9-13.
VIEW INSTRUCTIONAL VIDEO
TRANSSEPTAL ACCESS USING SAFESEPT GUIDEWIRE
Watch entire video including Feature overview and Suggested Procedure. 4:38
VIEW INSTRUCTIONAL VIDEO IN SECTIONS
DEVICE FEATURES
Device description and feature overview. 1:32
TRANSSEPTAL ACCESS:
A SUGGESTED PROCEDURE
Achieving access, positioning and penetration of the fossa ovalis for LA access. 1:59
WARNINGS, INDICATIONS, AND CONTRAINDICATIONS
Important information regarding the SafeSept. 1:01
Radiopaque coil makes the 0.014 inch diameter wire easily visible fluoroscopically
Specially designed tip configuration requires less force than a standard transseptal needle, enabling effortless penetration of the fossa
‘J’ shape allows safe advancement to assure proper wire location within left atrium
Transseptal needle and dilator are rendered atraumatic when tracking over the SafeSept
Proximal marker bands help determine SafeSept tip location relative to trans-septal needle tip during the procedure
135cm length for compatibility with all currently available adult transseptal introducer systems
SAFESHEATH INTRODUCERS AND SEALING ADAPTERS
SAFESHEATH CS AND LV INTRODUCERS
RIGHT-SIDED CS / RV ACCESS INTRODUCER
CORONARY SINUS VENOGRAPHY BALLOONS
ACCESSORIES
TRANSSEPTAL ACCESS
HEMOSTASIS & COMPRESSION MANAGEMENT
PACEMAKER PROTECTION AND COMFORT
Search Pressure Products
PRODUCTS
PROCEDURES
EDUCATION
ORDER
Pressure Products offers a complete line of vascular access and lead delivery systems and accessories, as well as medical devices for femoral and pacemaker pocket hemostasis.
Copyright © 2022 Pressure Products Medical Supplies, Inc. All rights reserved.