Interventional cardiology technology developer Franklin Mountain Medical has secured U.S. Food and Drug Administration (FDA) clearance for its UltraNav transseptal dual-lumen catheter.
Designed to enable access and delivery of cardiovascular catheters and guidewires to the heart chambers via transseptal puncture, UltraNav enables both intracardiac echocardiography (ICE) catheters and transseptal needles or catheters to be delivered simultaneously through one dual-lumen device, according to the firm.
As both catheters are fixed into position together, the ultrasound beam can lie in the same plane as the catheters and provide visualization of catheter orientation, needle length, and needle-tip location relative to the cardiac structure, the company said.
What's more, these ultrasound images are continuous and not interrupted by the patient's cardiac or respiratory cycle, according to Franklin Mountain Medical, a subsidiary of Franklin Mountain Capital.
