SafeSept Needle Free Transseptal Guidewire Receives FDA Market Clearance
One-step device provides access from right to left side of heart without transseptal needle
January 28, 2014
January 28, 2014 — The U.S. Food and Drug Administration (FDA) approved Pressure Products Inc.’s SafeSept Needle Free Transseptal Guidewire for use with any introducer system when crossing the interatrial septum. The device assists in transseptal procedures and is designed to create the primary puncture in the interatrial septum providing access from the right to left side of the heart without using a transseptal needle.
The SafeSept Needle Free Transseptal Guidewire’s very sharp tip requires little force to perforate and cross the fossa. Once penetrated and unsupported by the dilator and sheath, the tip assumes a ‘J’ shape, making it incapable of further tissue penetration. A radiopaque coil allows for fluoroscopic visualization in the left atrium and subsequent pulmonary veins.
For more information: www.pressure-products.com