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ENvizion's Personalized Feeding Tube Placement Device Receives FDA 510(k) Clearance
TEL AVIV, Israel, April 2, 2019 /PRNewswire/ --
- The ENvue Electromagnetic Feeding Tube Placement (EFTP) system is designed to enable accurate positioning of feeding tubes at the patient's bedside
- Proven safe and effective in ENvue clinical trials, with no tube insertions into the pulmonary airways
- Over 22 million feeding tubes are placed annually
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 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 US 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).
ENvizion Medical's is a privately held medical device company, in the field of nasoenteral feeding.
The company's ENvue™ Electromagnetic Feeding Tube Placement System, including nasoenteral feeding tubes, supports the rising clinical need for a safe and accurate feeding tube placement solution, contributing to patient health and improved healthcare. Cleared and indicated for use in the USA, the ENvue system features our proprietary electromagnetic placement technology.
Founded in 2014, ENvizion is located in Tel Aviv, Israel, with US headquarters in Minneapolis, MN.
Connect on LinkedIn: https://www.linkedin.com/company/envizionmedical/
Doron Besser, M.D.
CEO ENvizion Medical Ltd.
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SOURCE ENvizion Medical