US-based Pressure Products has obtained the US Food and Drug Administration (FDA) approval for its SafeSept needle free transseptal guidewire for use with any introducer system when crossing the interatrial septum.
SafeSept, which assists in transseptal procedures, is designed to create the primary puncture in the interatrial septum and provide access from the right to left side of the heart without using a transseptal needle.
The device features a very sharp tip which reduces the force required to perforate and cross the fossa. The tip assumes a J shape once it is penetrated and unsupported by the dilator and sheath. This shape makes it incapable of further tissue penetration.
Radiopaque coil of the SafeSept needle free transseptal guidewire allows for fluoroscopic visualization in the left atrium and subsequent pulmonary veins.
Over the wire advancement of the transseptal dilator and sheath into the left atrium is accomplished without the use of a transseptal needle.
Royal Sussex County Hospital consultant electrophysiologist Dr James McCready noted the SafeSept needle free has become his preferred method for all transseptal punctures.
"Issues with thickened or floppy septums and concerns about scraping plastic from the inside of dilators have been eliminated. When the wire has not been available, I find going back to using a traditional needle awkward and uncomfortable," Dr McCready added.