Endoscopy Stent Tracker App for the AXIOS™ Stent Assists Physicians with Tracking Patients

The Boston Scientific Endoscopy Stent Tracker is a supplemental informational tool that does not substitute for or replace existing patient record keeping by the physician. The Boston Scientific Endoscopy Stent Tracker does not constitute professional medical recommendations, treatment, or advice. It is not intended to be used to diagnose, cure, treat, or prevent any condition or disease.

The AXIOS™ Stent and Electrocautery-Enhanced Delivery System Indications for Use:

• US: The AXIOS Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts 6cm in size, with ? 70% fluid content that are adherent to the gastric or bowel wall. Once place, the AXIOS Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.

• Europe: The Hot AXIOS Stent and Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst, walled-off necrosis (?70% fluid content) or the biliary tract.

Note: The Caution statements below are specific to the AXIOS Stent and Delivery System devices and are not applicable to the AXIOS Stent Tracker. The AXIOS Stent Tracker is not a medical device.