Pentax Medical, a division of Hoya Group, has introduced an advanced DEC HD duodenoscope in the US.
The high-definition duodenoscope includes multiple disposable components, including the sterile distal cap and elevator lever, for unit reprocessing.
Pentax has developed DEC HD Duodenoscope to offer physicians with a solution aligned with recent US Food and Drug Administration (FDA) guidance on decreasing endoscope reprocessing and deliver tangible “Triple Aim” value.
Pentax Medical has recently secured FDA approval for DEC HD Duodenoscope
The device, which has been available in global markets since 2017, has recently secured approval from the FDA.
The FDA’s Center for Devices and Radiological Health director Dr Jeff Shuren said: “Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices.”
The hygienic endoscopic solution will help physicians to maintain the imaging and handling performance required during endoscopic retrograde cholangiopancreatography (ERCP) procedures. It will enable to easily dispose of the elevator, the component most vulnerable to enteric bacteria.
Featuring a sterile and disposable distal cap plus a disposable elevator, the duodenoscope allows minimising the risk of bioburden remaining on conventional elevator components after reprocessing.
Pentax Medical global chief clinical officer Dr Hudson Garrett said: “The DEC represents a significant clinical innovation both in device design and patient safety due to its sterile and disposable distal end cap with integrated elevator, and also a human factors-validated approach to both reprocessing and competency-based training.
“The DEC was specifically designed in response to the evidence-based recommendations released by the FDA and CDC and represents a critical step forward in improving patient safety, reducing contamination, and optimizing endoscope reprocessing programs.”
Pentax’s advanced duodenoscope with HD imaging will allow the endoscopist to diagnose and visualise the mucosa in detail, identify abnormal tissue, and locate the papilla for cannulation.
In August 2018, Pentax Medical purchased a controlling stake in French firm PlasmaBiotics for an undisclosed sum.
