Additional Clearance Granted for Spirus
The Endo-Ease Discovery SB device, designed and manufactured by Spirus Medical, received an expanded indication from the FDA according to the FDA News website. The device utilizes a unique over-the-tube approach to endoscopy requiring simple rotation to advance such through the gastrointestinal tract.
The Endo-Ease system is based on the company’s platform technology, Endoluminal Advancement System. This design incorporates a spiral on the leading end of various tubes utilized. The system supports improvement in both diagnostic and therapeutic tools that are passed through anatomical lumens. These updated designs can reduce the amount of trauma and discomfort to patients, as described by the manufacturer.
The Endo-Ease Endoluminal Advancement System is an updated version of systems for flexible endoscopy. The Endo-Ease Discovery SB specifically supports antegrade introduction by facilitating passage of the compatible endoscopes past the Ligament of Treitz. When the system is rotated, the endoscope moves past the Ligament to pleat the segment of the small bowel, which is a common site of disease.
Additional benefits of the new device include the ability to maneuver the enteroscope independently while it remains stationary. This single use system can be integrated with existing endoscopy equipment that are up to 9.4 mm OD.
May 26, 2008 Related topics: Product Approval & Certification