FDA approval for SafeSept NF needle free transseptal guidewire

San Pedro, Calif. - Pressure Products, a medical device company in the U.S., has obtained the U.S. Food and Drug Administration (FDA) clearance for its SafeSept NF needle free transseptal guidewire, designed for use with any introducer system when crossing the interatrial septum.

The advanced one-step device creates a 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.

The very sharp tip of the SafeSept needle free transseptal guidewire requires little force to perforate and cross 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 allows for fluoroscopic visualisation in the left atrium and subsequent pulmonary veins.

Once proper guidewire location is confirmed, advancement of the transseptal dilator and sheath over the wire into the left atrium is accomplished without the use of a transseptal needle.

The SafeSept needle free transseptal guidewire is designed to replace a transseptal needle with improved safety and less force when supported by a transseptal introducer.

Source: Pressure Products