Gastrostomy tubes, which help patients receive long-term nutritional support, are usually placed endoscopically and are required to be replaced every three to six months
Fidmi Medical, a portfolio company of The Trendlines Group, announced that the US Food and Drug Administration (FDA) has granted 510(K) approval for its low-profile enteral feeding device.
Founded in 2014, the Israeli medical devices manufacturing firm is involved in the development of enhanced feeding devices for easy insertion, replacement and removal.
Fidmi Medical CEO Shahar Millis said: “Receiving FDA clearance is a remarkable milestone for us. FDA clearance allows us to enter the US market; to provide improved patient quality of life and impact the ease, efficiency and confidence of clinicians’ work.”
Fidmi Medical’s improved low-profile gastrostomy tube is durable and comfortable
According to Fidmi, gastrostomy tubes help patients in receiving long-term nutritional support. The tubes are usually placed endoscopically and are required to be replaced every three to six months.
Common complications, including clogging and dislodgement, lead to inadequate nutrition, medication delivery, numerous tube replacements, hospitalisations, and a considerable financial drain on patients and the healthcare system.
The company said that the gastrostomy tubes usually get dislodged or clogged, resulting in infection. The tubes must be replaced frequently to avoid infection.
Fidmi Medical claimed that its advanced low-profile gastrostomy system is a unique device that can be used for initial placement and replacement, and is more durable and comfortable for patients.
The feeding device can be placed just like any regular Percutaneous Endoscopic Gastrostomy (PEG) tube. However, the new device features an easily replaceable inner tube, which can be changed by patients, avoiding the need to visit the healthcare system for replacement procedures.
Fidmi said that its new device will reduce complications with patients’ gastric tubes, reduce healthcare costs for payers and healthcare systems, and provide considerable improvement in quality of life for patients and their caregivers.
In September, Fidmi announced a collaboration with US-based CoapTech to develop a broader solution for tube-supported patients.