CoapTech announced today that it received CE mark approval and an approved CPT procedure code for its PUMA-G ultrasound gastrostomy system.
Baltimore-based CoapTech’s PUMA platform consists of minimally invasive devices designed to enable ultrasound for use in procedures in hollow organs of the body in which it was previously impossible or unsafe to do so, according to a news release.
PUMA-G, the first application of the PUMA platform, holds FDA clearance as a procedural kit allowing bedside clinicians — rather than consultant specialists — to place gastrostomy tubes solely using ultrasound alongside existing skillsets and their teams.
With the newly obtained CE mark approval, CoapTech said it intends to begin a targeted launch of PUMA-G in Europe later this year.
“CE Mark approval allows the PUMA-G System to be sold in Europe and is a major milestone enabling CoapTech’s commercial success,” CoapTech co-founder & CEO Howard Carolan said in the release. “Additionally, recent granting of a CPT code by the American Medical Association will facilitate coding and billing for users of PUMA-G for performing our new ultrasound gastrostomy procedure. This is a key enabler during our pilot commercialization phase, during which we continue to see significant interest in PUMA-G.”
CoapTech also noted that it had new safety studies accepted for publication. For example, a study published in The Journal of Intensive Care Medicine demonstrated that the company’s ultrasound gastrostomy procedure could be readily performed in intensive care units and was beneficial in use on COVID-19-positive patients.
Further results published in Abdominal Radiology confirmed that PUMA-G offered a safety profile on par with conventional gastrostomy methods, CoapTech added.
“With these studies, CoapTech and our research partners have established that ultrasound gastrostomy (PUG) is safe, can be performed in the ICU, and is valuable in the post-COVID world,” founder & CMO Dr. Steven Tropello said. “Future studies will identify additional benefits, including efficiency and cost advantages of our method and the PUMA-G device.”