Healthcare Industry News:  Transseptal Needle 

Devices Cardiology FDA

 News Release - January 24, 2014

SafeSept(R) Needle Free Transseptal Guidewire Receives FDA Market Clearance

Advanced one step device provides access from the right side of the heart to the left side, without the need for a Transseptal Needle

SAN FRANCISCO--(Healthcare Sales & Marketing Network)--Pressure Products, Inc., ( announced today that the United States Food and Drug Administration has approved the 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 NF adds another level of safety for TSP especially those done under fluoroscopy guidance alone and has overcome difficult cases of high fibrotic resistance,” says Dr. Anthony Chow, MBBS, BSc, MD, FRCP, consultant cardiologist (electrophysiologist) at The Heart Hospital, UCLH, London, UK.

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. “Over the wire” advancement of the transseptal dilator and sheath into the left atrium is accomplished without the use of a Transseptal Needle.

“The SafeSept Needle Free has become my 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,” says Dr. James McCready, MBBS MRCP, consultant electrophysiologist, Royal Sussex County Hospital, Brighton, UK. “When the wire has not been available, I find going back to using a traditional needle awkward and uncomfortable.”

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Pressure Products offers a complete line of hemostatic peel-away and sliceable introducers and accessories, as well as medical devices for femoral and pacemaker pocket hemostasis. The company launched in 1988 by two cardiologists who continue to explore the development of innovative medical products with one goal in mind: improve patient care.

Source: Pressure Products Inc

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