US-based medical devices company CoapTech announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its PUMA-G System, which is used for ultrasound-based placement of percutaneous gastrostomy feeding tubes.
Image: CoapTech secures FDA 510(k) clearance for PUMA-G System. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
CoapTech is a medical device company focused on delivering transformative solutions for minimally-invasive surgery.
Patients who cannot eat or swallow food are dependent on feeding tubes for enteral nutrition via a tube through the abdominal wall directly into their stomach.
Conventional procedures to place feeding tubes typically require a surgical suite, additional specialty consultant providers, and expensive and invasive imaging.
CoapTech founder and chief medical officer Steven Tropello has invented the PUMA-G System, an ultrasound gastrostomy system that helps physicians to place gastrostomy tubes at the point of care, using solely ultrasound imaging.
The PUMA-G System is capable of improving the efficiency, safety, and cost-effectiveness along with expanding the access to the therapy for nutrition administration, by eliminating the need for a surgical suite.
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.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 utilize 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.”
CoapTech said that the PUMA-G System forms the first approved application of its Point-of-care Ultrasound Magnet Aligned (PUMA) System platform, which enables ultrasound to work in hollow organs of the body for novel diagnostic or interventional procedures.
CoapTech CEO Howard Carolan said: “Our hardworking team is honored to have received FDA clearance as we continue our mission for safer, simpler, and faster patient care.
“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.”