FDA Ruling Expands Patient Access to Video Capsule System

PENTAX Medical, a healthcare industry leader in diagnostic and therapeutic endoscopy solutions, announced the expanded availability of the CapsoCam Plus video capsule system, an ingestible small bowel capsule endoscope, as part of an Discretionary Enforcement Policy enacted by the U.S. Food and Drug Administration (FDA) to expand the availability of remote digital pathology during the COVID-19 pandemic.
 
The special expanded labeling grants patients access to a mechanism for evaluating the small intestine, a part of the bowel that cannot be reached by traditional upper endoscopy or colonoscopy, while eliminating the need for in-person interactions between clinicians and their patients.
 
“Because the CapsoCam Plus delivers high quality images sufficient for full visualization of the small bowel of the mucosa, patients are not just being offered an alternative option for endoscopy under the FDA’s special designation; instead, patients are gaining expanded access to a technology for detecting a wide range of conditions affecting the small intestine,” said Rainer Burkard, chief commercial officer, PENTAX Medical, Americas. “The FDA’s recent action is extremely important in the midst of a pandemic as it allows patients to stay home and stay safe while maintaining access to crucial diagnostic services.”
 
The CapsoCam Plus video capsule system, which is manufactured by CapsoVision Inc. and distributed exclusively in the United States and Canada by PENTAX Medical, is the only self-contained capsule endoscopy system that does not require external equipment that must be worn by the patient. Eligible patients swallow the device under supervision of a physician during a video call. As the pill-sized device passes through the middle portion of the gastrointestinal tract, it captures 360-degree visualization of the duodenum, jejunum and ileum. The footage is later downloaded and placed on the cloud for physician review.
 
“The ability to perform any test remotely minimizes the exposure of patients and physicians, which has become especially important during the COVID-19 pandemic. Patients can be seen during a telemedicine appointment scheduled at their convenience and in the comfort of their own home, yet still have access to an important cutting-edge diagnostic procedure. In some instances, such as for patients with intermittent bleeding episodes, the timing of testing can be improved, which increases the yield of the test,” said Javier L. Parra, M.D., a gastroenterologist with Gastro Health in Miami.
 
The CapsoCam Plus video capsule system is the only capsule endoscopy system on the market with 360-degree lateral viewing ability. Importantly, the device contains its own light source and images are stored on the device, thus eliminating the need for patients to wear an external sensor belt or recording instrument. This exclusive feature of the CapsoCam Plus video capsule system improves comfort, reduces associated costs, and increases ease of use. After the capsule has passed through the system, a specialized retriever tool is used to collect the capsule, which is then packaged and shipped to a laboratory. Once there, images are retrieved and loaded to the CapsoCloud, a HIPPA-compliant data management and storage system that connects to the CapsoView software interface for physician viewing and evaluation.
 
“Even under normal conditions, many patients are uncomfortable with or unable to come to the office for endoscopic or capsule endoscopy procedures. The FDA’s recent special enforcement policy to allow for Remote Tele Ingestions in response to the COVID-19 pandemic, provides gastroenterologists access to a technology that eliminates the need for patients to make multiple trips to the office, which is especially important for elderly patients and those with comorbidities. The protocol that CapsoCam Plus provides is simply not available with any other device on the market today,” said Ian M. Storch, D.O., FACP, FACG, a gastroenterologist with St. Francis Hospital in Hyde Park, N.Y.
 
This FDA’s Discretionary Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency was enacted to expand the availability of remote digital pathology devices that may help facilitate pathology services while reducing healthcare personnel contact and risk of potential exposure to COVID-19 through remote reviewing and reporting. The policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 as declared by the U.S. Department of Health and Human Services (HHS).