The EndoRotor system will help resect and remove necrotic tissue in patients with walled-off pancreatic necrosis
The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Interscope has secured marketing authorisation from the US Food and Drug Administration (FDA) for its EndoRotor system to remove dead pancreatic tissue.
The authorisation permits the use of the system to resect (cut out) and remove necrotic (dead) tissue in patients with walled-off pancreatic necrosis (WOPN), a serious condition that may occur several weeks after an event of acute pancreatitis.
EndoRotor system consists of a power console, foot control, specimen trap and single-use catheter.
The system is suitable for use in a procedure known as direct endoscopic necrosectomy, which mainly includes two steps.
During the first step, the user has to use a metallic stent to create a portal between the stomach and the necrotic cavity in the pancreas.
The portal is said to accommodate a standard endoscope, which is a flexible tube with a light and camera attached to help view the procedure.
During the second step, the user has to place the EndoRotor via the working channel of the endoscope to cut and remove the necrotised tissue.
The regulator evaluated the safety and effectiveness of the EndoRotor system in a trial with 30 subjects with walled-off pancreatic necrosis who had been determined to undergo a direct endoscopic necrosectomy. Study subjects were treated using the EndoRotor system during the procedure.
FDA Centre for Devices and Radiological Health’s reproductive, gastro-renal, urological, general hospital device and human factors office acting director Dr Charles Viviano said: . “Currently, in order to remove dead tissue from a patient’s necrotic pancreatic cavity, health care providers need to perform an invasive surgery or use other endoscopic tools not specifically indicated to treat this condition.
“With today’s marketing authorisation, patients with walled-off pancreatic necrosis now have a new treatment option.”
In December 2019, Interscope secured FDA approval for the EndoRotor system for use in pulmonary indications. The approval enabled to use the EndoRotor system in airway procedures, including interventional pulmonology.