Saturday, December 26, 2020
Interscope, Inc. announced today the receipt of FDA de novo clearance to market its EndoRotor® System in the United States for direct endoscopic necrosectomy (DEN), a 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 (4) procedures in order to clear the necrosis and is associated with a complication rate of approximately 22%.1 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 (2) 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 sixteen (16) days as compared to an average of 32 days reported in literature.1-3
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."
Acute pancreatitis is estimated to effect 415,000 patients annually in the United States and progresses to walled-off necrosis (solid diseased tissue) in approximately 20% of patients.4,5 While walled-off necrosis 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.4 Studies have documented the need for dedicated instruments to perform the DEN procedure due to the high risk for complications. 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 of the 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."
Interscope previously announced the receipt of FDA 510(k) clearance to market the EndoRotor System for the management of post endoscopic mucosal resection (EMR) tissue persistence with a scarred base and for removal of endobronchial tumors and granulation tissue in December 2018 and December 2019 respectively. Several clinical trials have since been completed identifying the EndoRotor as a critical tool for physicians to use during these interventional endoscopic procedures.
