Franklin Mountain Medical this week announced its UltraNav transseptal catheter system has received FDA 510(k) clearance

The Phoenix, Arizona-based company designed UltraNav for controlled access and delivery of cardiovascular catheters and guidewires into the heart chambers through a transseptal puncture. The dual-lumen catheter enables side-by-side and simultaneous delivery of both ICE and transseptal needles or catheters through one dual-lumen device.

The success of transseptal procedures is dependent upon a clinician’s ability to visualize the heart’s internal anatomy and the catheters/needles being used, according to the company. Increased visualization allows for precise puncture of the septum and catheter delivery, including intracardiac echocardiography catheters.

UltraNav enhances visualization of catheter orientation, needle length and needle tip location relative to the cardiac structure. Since the catheters are fixed in position together, the ultrasound beam lays in the same plane as the transseptal catheter to create continuous visualization without interruptions from the patient’s cardiac or respiratory cycle.

“The complete, continuous visualization and delivery of catheters will result in more precise punctures and easier catheter navigation, which should improve the safety and performance of septal puncture and structural procedures. Compared to current practice, this will reduce scheduling complexity, reduce procedure cost and shorten overall procedure times. It should also provide the option of conscious sedation over general anesthesia when appropriate. I am very excited about the impact the UltraNav System can have on transseptal procedures,” said Dr. Nabil Dib, founder and president of the International Society for Cardiovascular Translational Research.