An innovative direct endoscopic necrosectomy (DEN) system provides a minimally invasive option for resection and aspiration of walled-off pancreatic necrosis.

The Interscope (Northbridge, MA, USA) EndoRotor System includes a power console, foot control, specimen trap, and a single-use catheter. During the DEN procedure, the user first creates a lumen using a metallic stent or cystogastrostomy between the stomach and the necrotic cavity in the pancreas; the portal accommodates a standard endoscope. The EndoRotor is then inserted into the working channel of the endoscope to simultaneously resect and aspirate the necrotic material from the walled-off pancreatic collection under direct endoscopic visualization.

An average of two procedures is required to complete necrosectomy. Studies have shown an average of 85% reduction in the amount of necrotic tissue using the system, with half of the subjects having 98.5% clearance of their necrotic tissue. The EndoRotor System should not be used in patients with known or suspected pancreatic cancer, documented pseudoaneurysm, intervening gastric varices, or unavoidable blood vessels within the access tract, and should only be used following other procedures to drain the walled-off pancreatic necrosis (WOPN).

“Physicians now have a dedicated solution to treat this severe and potentially lethal condition. The EndoRotor has shown to be a welcomed improvement in safety and effectiveness that will enhance patient care and allow interventionalists to continue saving lives,” said Jeffery Ryan, CEO of Interscope. “We are proud of this achievement as we begin the commercial launch of the first and only dedicated system for direct endoscopic necrosectomy.”

“Currently, in order to remove dead tissue from a patient's necrotic pancreatic cavity, health care providers need to perform invasive surgery or use other endoscopic tools not specifically indicated to treat this condition,” said Charles Viviano, MD, PhD, of the FDA Center for Devices and Radiological Health (CDRH). “This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with WOPN, which occurs in about 15 percent of patients with severe pancreatitis.”

Pancreatitis occurs when digestive enzymes and inflammation cause cellular damage or tissue death. Necrotizing pancreatitis occurs when part of the pancreas dies because of inflammation or injury. After several weeks, the area of necrosis may form a cavity, turning into a WOPN. While WOPN is routinely managed with endoscopic ultrasound guided drainage procedures, approximately 30% of patients with the condition become infected, resulting in lengthy hospitalization, multiple endoscopic procedures, conversion to surgery, and potentially death.

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