FDA Authorizes Marketing Of The EndoRotor System

On December 23, the U.S. Food and Drug Administration (FDA) authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal.

“This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis, which occurs in about 15 percent of patients with severe pancreatitis,” said Charles Viviano, M.D., Ph.D., acting director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for Devices and Radiological Health. “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 authorization, patients with walled-off pancreatic necrosis now have a new treatment option.”

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 walled off cavity and become what is called walled-off pancreatic necrosis. It is necessary to remove the dead tissue if it becomes symptomatic, such as worsening pain, causing infection which can lead to sepsis, or resulting in an obstruction to the intestines.

The American Cancer Society’s estimates for pancreatic cancer in the United States for 2020 are:

• About 57,600 people (30,400 men and 27,200 women) will be diagnosed with pancreatic cancer.
• About 47,050 people (24,640 men and 22,410 women) will die of pancreatic cancer.
• Pancreatic cancer accounts for about 3% of all cancers in the US and about 7% of all cancer deaths.

It is slightly more common in men than in women. A risk factor is anything that increases your chance of getting a disease such as cancer. Different cancers have different risk factors. Some risk factors, like smoking, can be changed. Others, like a person’s age or family history, can’t be changed.

In some cases, there might be a factor that may decrease your risk of developing cancer or has an unclear effect. That is not considered a risk factor, but you may see them noted clearly on this page as well. Having a risk factor, or even many, does not mean that you will get cancer. And some people who get cancer may have few or no known risk factors.

The EndoRotor System

The EndoRotor System includes a power console, foot control, specimen trap and single-use catheter, and is used in a procedure called direct endoscopic necrosectomy that broadly consists of two steps. First, the user creates a portal, typically using a metallic stent, between the stomach and the necrotic cavity in the pancreas. This portal accommodates a standard endoscope—a flexible tube with a light and camera attached to aid in viewing the procedure. Second, the user places the EndoRotor through the working channel of the endoscope to cut and remove the necrotized tissue.

The device’s effectiveness was studied by how well it cleared necrotic tissue from the subject’s pancreas. The amount of necrotic tissue in each subject’s pancreas was measured during a computerized tomography scan with contrast before the procedure and compared to a follow up CT scan, endoscopy or MRI 14 to 28 days after the last procedure.

For subjects undergoing procedures with the EndoRotor System, there was an average of 85% reduction in the amount of necrotic tissue, with half of the subjects having 98.5% clearance of their necrotic tissue.

“The EndoRotor System should not be used in patients with walled-off necrosis who have a documented pseudoaneurysm (when a blood vessel wall is injured and the leaking blood collects in the surrounding tissue) greater than 1 cm within the cavity or with intervening gastric varices (swollen veins in stomach) or unavoidable blood vessels within the access tract; or in patients with known or suspected pancreatic cancer,” – the FDA warns.