Gallbladder drainage without a drain? Introducing the AXIOS™ Stent

The gallbladder is a pear-shaped organ about three inches long that sits just underneath the liver. Each time a person eats fatty foods, their gallbladder releases a dose of a greenish fluid called bile into the neighboring small intestine to help digest the fats. However, if the duct from the gallbladder becomes blocked, the bile is trapped and the gallbladder becomes inflamed, which is called acute cholecystitis. This condition has been diagnosed in up to 200,000 people in the U.S. each year and often requires urgent care.

In most cases, acute cholecystitis is treated by removing the gallbladder. But the surgery is considered too risky for certain patients, including the elderly, critically ill people and those with significant health issues. The most common alternative treatment is percutaneous transhepatic gallbladder drainage (PT-GBD), in which a thin tube is placed through the skin and inside the gallbladder that drains the bile into a bag outside the body. While PT-GBD is considered safe and effective, it does have a potential downside: The drainage tube remains in the patient, along with an external fluid collection bag they wear underneath their clothing – sometimes for life.

Patients can be upset at the prospect. Not only does the bag get in the way of their daily activities, but it also requires a good deal of maintenance, including being emptied each day, flushing the drain with saline and changing any bandages to prevent infection. For patients with dementia, an external drain can pose an additional risk: they’re prone to pulling it out.

“An external drain can be a real hardship,” says Brian Dunkin, M.D., chief medical officer, Endoscopy at Boston Scientific. “We wanted to give patients that aren’t candidates for surgery a safe and effective alternative.”

Now, Boston Scientific has a solution for high-risk acute cholecystitis patients that doesn’t involve an external drain: the AXIOS™ Stent and Electrocautery Enhanced Delivery System, the first and (as of this writing) only endoscopic treatment for gallbladder drainage available in the U.S.*

First-of-its-kind technology for gallbladder drainage

In a procedure using an AXIOS Stent, a doctor passes a flexible tube called an echoendoscope through the mouth of a patient under anesthesia and into the gastrointestinal tract until it reaches the stomach or small intestine. This endoscope has a tiny camera and a specialized probe at the tip so that the doctor can get a good view of the gallbladder using ultrasound, the same imaging technology used for “seeing” inside a pregnant woman’s belly.

That’s when the procedure’s second phase can begin: Putting the AXIOS Stent into place.

A stent is a tiny wire mesh tube physicians use to prop open a narrow pathway within the body, such as a blood vessel or a duct. The AXIOS Stent looks a bit different than a typical stent. It flares outwards at both ends, like a dumbbell, to keep it firmly anchored once placed inside the body.

The doctor makes a small hole through the wall of the small intestine or stomach and into the gallbladder, then places the AXIOS Stent to create a passageway that connects the two organs. Now, the infected contents of the gallbladder can flow through the stent and into the GI tract, where it will be eliminated from the body as waste – with no need for any external drainage.

Studies have found the benefits of AXIOS go beyond eliminating the need for an external drain: in a randomized multicenter controlled superiority trial, treating non-surgical candidates with an AXIOS Stent instead of PT-GBD also resulted in fewer complications, lower reoccurrence rates, fewer reinterventions and less post-procedure pain.

Ready to meet the needs of U.S. patients

The AXIOS Stent and its delivery system have been used for gallbladder drainage in Europe, Canada and Australia since 2013. In the U.S., where it was previously FDA-cleared for managing certain pancreatitis complications, AXIOS was also cleared for gallbladder drainage in 2023 and became available to physicians and patients this past June. As such, it joins a wider Boston Scientific portfolio of devices that treat gallbladder disease, making available yet another tool to use in a multidisciplinary approach to a complex disease. And perhaps most importantly, it offers patients who qualify a unique opportunity to live a drain-free life.

Learn more about acute cholecystitis and gallbladder drainage solutions.

*U.S. Gallbladder indication is for 10mm×10mm and 15mm×10mm stents only. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com.