Interscope’s EndoRotor System granted FDA De Novo clearance for necrosectomy
Interscope has received the US Food and Drug Administration (FDA) de novo clearance to market its EndoRotor System in the country for direct endoscopic necrosectomy (DEN).
Interscope has received the US Food and Drug Administration (FDA) de novo clearance to market its EndoRotor System in the country for direct endoscopic necrosectomy (DEN).
The DEN procedure is a minimally invasive treatment for walled-off pancreatic necrosis.
Acute pancreatitis progresses to walled-off necrosis (solid diseased tissue), which is managed using endoscopic ultrasound-guided drainage procedures.
Estimates show that around 30% of the patients get infected leading to lengthy hospitalisation, multiple endoscopic procedures, and conversion to surgery, which can even result in death.
The EndoRotor System aids the physician in simultaneous resection and aspiration of necrotic material from a walled-off pancreatic collection under direct endoscopic visualisation through a lumen apposing metal stent or cystogastrostomy.
Data from the recently concluded FDA Investigational Device Exemption (IDE), which had 30 patients in the US and Europe, showed that an average of two procedures was needed to perform necrosectomy.
In addition, no complications related to the use of EndoRotor and a 10% procedural complication rate was observed.
Also, trial patients were hospitalised for an average of 16 days as compared to the 32 days reported.
In 2018, the system had received the CE Mark of approval in Europe for the same indication.
Interscope CEO Jeffery Ryan said: “Physicians now have a dedicated solution to treat this severe and potentially lethal condition.
“The EndoRotor has shown to be a welcome improvement in safety and effectiveness that will enhance patient care and allow interventionalists to continue saving lives.”
Over 30 investigators in the US and Europe were involved in the clinical validation of EndoRotor.
Earlier, Interscope received FDA 510(k) clearance to market the EndoRotor System for management of post-endoscopic mucosal resection tissue persistence with a scarred base, as well as for endobronchial tumour and granulation tissue removal.