2014

AXIOS™ Stent and Delivery System Study Demonstrates Successful Treatment of Pancreatic Pseudocysts and Acute Cholecystitis Peer-Reviewed Paper Validates Promise of New Transenteric Therapy

MOUNTAIN VIEW, Calif., May 15, 2012 /PRNewswire/ -- Xlumena, Inc. announces the publication of a scientific paper describing the first human study of the AXIOS™ Stent and Delivery System. The article, entitled "Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage" appeared in the April issue of Gastrointestinal Endoscopy – the leading journal for advances in endoscopy.

The research reports technical and clinical success using the AXIOS Stent to treat 15 pancreatic pseudocyst and 5 acute cholecystitis patients. All the pseudocysts and cholecystitis symptoms resolved and did not recur during the 9 month follow-up period. There were no complications during stent placement or removal.

Pancreatic pseudocysts are painful and potentially dangerous fluid-filled sacs most often resulting from pancreatitis. They can be treated surgically, percutaneously or endoscopically. Cholecystitis, or inflammation of the gallbladder, is usually alleviated by surgically removing the gallbladder. Patients who cannot undergo surgery have only the uncomfortable option of having a percutaneous (external) drain inserted into their gallbladder.

"This study demonstrates the promise of the AXIOS Stent," says Takao Itoi, MD of Tokyo Medical University Hospital and the paper's lead author. "We were able to successfully treat these very sick patients endoscopically and enable them to avoid more invasive procedures."

The stent provides a new approach for gallstone removal. "Two patients in the trial had gallstones. In one of these the stones came out on their own through the stent and in the other we were able to remove the stones. This is a unique and potentially clinically important development," adds Dr. Itoi.

Also interesting is that one cholecystitis patient in the study refuses to have the stent removed. "She had undergone frequent and repeated interventions for her cholecystitis symptoms without any lasting benefit. Since the stent was placed 18 months ago the symptoms have not returned and so the patient has insisted we leave the stent in place," says Dr. Itoi.

The stent is delivered under endoscopic guidance in four steps using a specially-designed catheter. All stents were successfully placed with no problems.

Kenneth Binmoeller, MD, a co-author, is the Medical Director of the Interventional Endoscopy Service (IES) at California Pacific Medical Center and Xlumena's Chief Medical Officer. "We saw no complications related to the stent in this study and it performed just as we had expected. The 10 mm stent opening provided effective drainage and remained patent throughout the study. Flanges on the ends of the stent held it in place. One stent placed into a pseudocyst did migrate into stomach, though this occurred after the pseudocyst had resolved."

Research on the use of the AXIOS Stent to treat cholecystitis has been on-going. A poster describing the successful treatment of 11 patients will be reported at the upcoming DDW 2012 meeting in San Diego. As with the current study, once the stent was placed the patients had immediate relief of their cholecystitis symptoms.

The AXIOS Stent and Delivery System is currently being sold in Europe for use in pancreatic pseudocysts. The AXIOS Stent is an investigational device (limited by federal law to investigational use) and is not commercially available in the United States. An Investigational Device Exemption Study is being conducted to determine if the stent can safely and effectively treat pancreatic pseudocysts.

About Xlumena, Inc.

Xlumena, Inc. is the leader in the development of image-guided therapeutic endoscopy products, specializing in advanced implants and devices for therapeutic endoscopists. Collaborating with top physicians in the field, Xlumena focuses on technologies that advance therapy to the next level. These innovations may enable numerous minimally invasive transenteric therapeutic interventions, helping transform complex surgeries into lower cost and less complicated outpatient procedures.

Xlumena and AXIOS are trademarks of Xlumena, Inc.

SOURCE Xlumena, Inc.



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