CoapTech gets 510(k) clearance for PUMA-G ultrasound system

30 April 2019 (Last Updated April 30th, 2019 12:58)

CoapTech has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ultrasound gastrostomy system, point-of-care ultrasound magnet aligned (PUMA)-G.

CoapTech has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ultrasound gastrostomy system, point-of-care ultrasound magnet aligned (PUMA)-G.

The PUMA-G system enables physicians to place percutaneous gastrostomy feeding tubes at the point of care with the help of solely ultrasound imaging.

PUMA-G is beneficial when compared to conventional procedures that require a surgical suite, additional speciality consultant providers, and expensive and invasive imaging.

The ultrasound-based system for placing enteral feeding tubes eliminates the need for a surgical suite and has the potential to improve safety and cost-effectiveness.

CoapTech founder and chief medical officer Steven Tropello said: “As a healthcare provider, I have seen the challenges with current gastrostomy methods, and the delays in care and potential harm to patients that can result.

“Clinicians trained in point-of-care ultrasound will be able to utilise the PUMA-G System to safely and swiftly place a G-tube at the bedside, which should keep patients progressing on their journey towards recovery and home.”

“The inspiration for this product came after seeing countless patients needing a simple G-tube insertion or replacement who needlessly wound up staying multiple days in the hospital waiting for a specialist and an operating room to be available.

“Clinicians trained in point-of-care ultrasound will be able to utilise the PUMA-G System to safely and swiftly place a G-tube at the bedside, which should keep patients progressing on their journey towards recovery and home.”

The company noted that the PUMA-G System is the first approved application of its PUMA System platform.

CoapTech CEO Howard Carolan said: “Based upon the success of the PUMA-G System to date, this milestone further motivates us to accelerate the development of other applications, expanding the PUMA platform to provide new solutions for ultrasound-guided procedures in other hollow organs of the body, such as the airway and lung.”