Medtronic has secured the 510(k) clearance from the US Food and Drug Administration (FDA) for its PillCam Small Bowel 3 system for remote endoscopy procedures.
By combining Medtronic’s PillCam technology with Amazon logistics, the PillCam SB3 @HOME programme provides timely and accurate results for patients from their homes.
The programme is designed to offer a telehealth option for direct visualisation and monitoring of the small bowel.
According to Medtronic, PillCam SB3 @HOME helps in the detection of lesions that may indicate Crohn’s disease, locate obscure bleeding, or identify sources of iron deficiency anemia (IDA).
The PillCam Small Bowel 3 system is designed to deliver images of the mucosa.
The system consists of adaptive frame rate technology to support image acquisition that is uniquely suited to each patient’s motility and the tools required to record those images.
It is only approved for remote use in the US.
Medtronic medical surgical portfolio’s gastrointestinal business president Giovanni Di Napoli said: “As the future of medicine continues to move toward remote settings, we have great opportunity to deliver diagnostic testing and other minimally invasive procedures from patients’ homes.
“The pandemic necessitated more remote innovation, and our capabilities have exceeded expectations to provide better quality care to patients without the risk of COVID infection and without adding to the burden on the medical staff.
“PillCam SB3 @HOME offers a convenient option for a contactless procedure and helps ensure that patients can access care in a timely manner.”
The PillCam SB3 @HOME programme allows a GI physician to place an order for a procedure kit after identifying a patient.
Once the order is placed, the procedure date is confirmed and the PillCam SB3 @HOME kit is delivered directly to the patient.
A healthcare provider will guide the patient through the remote procedure, upon completion of which the patient will return the data recorder and sensor belt to Medtronic.
During the eight-hour procedure, the PillCam SB3 capsule transmits approximately 50,000 images, which will transferred to the cloud to enable a GI physician to review the images for diagnosis.
