ENvizion Medical announced that the ENvue Electromagnetic Feeding Tube Placement System and ENvizion Feeding Tubes received FDA 510(k) clearance. This new generation of electromagnetic placement technology addresses current technological limitations and meets the growing clinical need for accurate feeding tube placement at the bedside.
 
Globally, over 22 million nasal feeding tubes are placed annually, out of which 6 million are in the USA. The main challenge is to place and position the tube correctly in the GI tract, avoiding the lungs. Current insertion methodologies are limited and it is estimated that 1 million tubes are misplaced annually worldwide. Misplacement of the tube in the lungs can cause significant patient injury, including death, and lead to prolonged hospital stay with extensive additional hospital costs.
 
This troubling challenge has significantly raised awareness among healthcare providers and patient advocacy groups, leading to the search for new dependable solutions.
 
ENvizion's unique technology enables accurate enteral placement. Using multiple sensors and an electromagnetic field, the ENvue system creates a personalized roadmap of the patient's anatomy, displaying continuous tube tip position within the body during the insertion procedure. The healthcare professional placing the tube has access to multiple views and warning indicators, which allows visual verification that the tube is proceeding along the correct path, and not entering the lungs.
 
Results from a clinical trial conducted at leading U.S. hospitals demonstrated that the ENvue system is safe and effective, with no tube insertions into the pulmonary airways and no occurrence of guidance-related adverse events.
 
Using the ENvue system has the potential to eliminate the need for additional placement verification methods (x-rays and pH measurements).