Boston Scientific Launches AXIOS Stent and Delivery System

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On March 22, 2016, Boston Scientific announced the launch of the AXIOS Stent and Electrocautery Enhanced Delivery System.  According to its website, the stent and delivery system helps physicians treat complications relating to pancreatitis. Last year, Boston Scientific, a medical device company that develops, manufactures, and markets minimally invasive medical devices, acquired the system in 2015 through a $75 million buyout of Xlumena. Xlumena develops products that enable advanced image-guided endoscopic therapy.

According to its website, the AXIOS stent, said to be MRI compatible and self-expanding, has two large flanges on each end of the lumen.  The flanges hold the tissue layers together.  This configuration reduces the risk of leakage and migration, and provides an effective drainage system.  Using the stent, physicians can treat patients endoscopically (through minimally-invasive techniques), rather than surgically (through invasive techniques).

According to the initial FDA press release, this system “is the first stent . . . specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract,” which bypasses blockages and strictures.

In particular, the FDA approved the system for endoscopic treatment of pancreatic pseudocysts and certain types of walled-off pancreatic necrosis. Pancreatic pseudocysts can occur when fluid and tissue-filled cavities form in the pancreas next to the stomach or small intestine.  Walled-off pancreatic necrosis occurs after the formation of pseudocysts, where enzymes are walled off by tissue.  The AXIOS stent delivery system helps to create a temporary channel between pancreatic fluid and the gastrointestinal tract and to facilitate drainage of the fluid.

The website describing AXIOS states that the system advantageously enables a faster hospital room turnover. As a result, the stent can reduce costs for the hospital and patient, reduce anesthesia time, and potentially reduce the length of X-ray exposure.  AXIOS’s inventor Kenneth Binmoeller, M.D. stated:

The Axios Stent and electrocautery enhanced delivery system provide a simpler and faster treatment option for patients” that can help physicians “provide[] immediate relief for patients using [only] one device in [only] a single setting.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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