#United States #Raleigh, NC #Arctx Medical #Cool Catheter #Acute Pancreatitis

Arctx Medical Achieves Major FDA Approval

Arctx Medical, Inc., a trailblazer in clinical-stage medical devices, has reached a pivotal achievement by obtaining FDA marketing authorization for its innovative product, the Arctx Cool Catheter™ Set (ACC). This groundbreaking device is primarily utilized for regulating body temperature and stands out due to its non-invasive design that eliminates the need for general anesthesia or vascular access.

A Closer Look at the Arctx Cool Catheter™ Set

The ACC features a uniquely constructed catheter, designed to be placed nasogastrically, through which either cold or warm water circulates in a closed circuit. This circulation allows for effective internal temperature management, making it a valuable option for patients in need of thermal regulation during medical treatment.

The approval is marked as a significant achievement for Arctx Medical, further establishing its commitment to innovation in medical technology.

Clinical Results and Future Prospects

Additionally, Arctx Medical has announced promising initial results from its First-in-Human (FIH) clinical trial regarding the ACC's effectiveness in treating Acute Pancreatitis (AP), a serious inflammation of the pancreas often leading to hospitalization. The results were highlighted at the prestigious American College of Gastroenterology annual conference, with Dr. Walter Park of Stanford University presenting the findings. He described the initial outcomes as