Transseptal Access System Cleared by FDA

The FDA granted 510(k) clearance for Transseptal Solutions’ TSP Crosser, a transseptal access system used for placing cardiovascular catheters in the left heart chambers.

Transseptal punctures are used to access the left side of the heart without having to place catheters in the aorta, by puncturing the septum that separates the left and right atria.

The device is comprised of a sheath, dilator and flexible puncturing needle, with a radiopaque loop wire at the end. The sheath can turn 180 degrees in either direction.