FDA De Novo approves to market EndoRotor System for Direct Endoscopic Necrosectomy (DEN)

Flexible Microdebrider Catheter - EndoRotor

Interscope, Inc. announced the release of FDA de novo clearance to market its EndoRotor System in the United States for direct endoscopic necrosectomy (DEN), minimally invasive treatment, for walled-off pancreatic necrosis. The EndoRotor System received CE Mark in Europe for this indication in 2018.

Current clinical data demonstrates the migration from surgical necrosectomy to DEN. While DEN is a safer approach, it involves the use of conventional instruments such as polypectomy snares and biopsy forceps, which are not specifically indicated or cleared for DEN. Therapeutic use of these devices requires an average of four procedures to clear the necrosis and is associated with a complication rate of approximately 22%. The EndoRotor System allows a physician to simultaneously resect and aspirate necrotic material from a walled-off pancreatic collection under direct endoscopic visualization through a lumen apposing metal stent or cystogastrostomy. The recently completed FDA Investigational Device Exemption (IDE), which enrolled 30 patients in the United States and Europe, demonstrated an average of two procedures to complete necrosectomy, no complications related to the use of EndoRotor, and a 10% procedural complication rate. Furthermore, trial patients were hospitalized for an average of 16 days as compared to an average of 32 days reported in the literature.

Interscope CEO, Jeffery Ryan, stated: “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. We are thankful for the FDA’s diligence. We are humbled by the contributions of Arjun Koch, Marco Bruno and the visionary collaborators who set us on this path. We are proud of this achievement as we begin the commercial launch of the first and only dedicated system for direct endoscopic necrosectomy.”

The clinical validation of the EndoRotor involved over 30 investigators in both the United States and Europe. Among trial investigators, Kenneth Binmoeller MD, San Francisco, CA and Inventor, Axios Stent, commented: “AXIOS extended the reach of the interventional endoscopist to walled-off pancreatic necroses. EndoRotor arms that reach with a powerful, dedicated tool for DEN.”