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# FDA Authorizes Interscope EndoRotor System
- URL: https://www.fdaweb.com/fda-authorizes-interscope-endorotor-system/
- Published: 2021-01-04T12:00:00.000Z
- Updated: 2026-09-14T16:41:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148350

FDA has authorized the marketing of Interscope’s EndoRotor system to resect and remove necrotic tissue for patients with walled-off pancreatic necrosis. An agency [statement](https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-new-device-designed-remove-dead-pancreatic-tissue?ref=fdaweb.com) says the system includes a power console, foot control, specimen trap, and single-use catheter, and is used in a direct endoscopic necrosectomy.

The system’s safety and effectiveness were assessed in a trial with 30 subjects (23 in the U.S.) with walled-off pancreatic necrosis who were indicated to undergo a direct endoscopic necrosectomy, FDA says. The device’s effectiveness was studied by how well it cleared necrotic tissue from the subject’s pancreas. For subjects undergoing procedures with the EndoRotor system, the statement says, there was an average of 85% reduction in the amount of necrotic tissue, with half of the subjects having a 98.5% clearance of their necrotic tissue.

In the trial, FDA says, three subjects experienced procedure-related serious adverse events. Two had gastrointestinal bleeding and one experienced pneumoperitoneum and later died from sepsis and multi-organ system failure caused by massive collections of infected pancreatic necrosis.

The device was reviewed through the *De Novo* pathway for some novel low- to moderate-risk devices.