|By PR Newswire||
|January 9, 2014 10:17 AM EST||
MOUNTAIN VIEW, Calif., Jan. 9, 2014 /PRNewswire/ -- Xlumena, Inc., a leader in advanced endoscopic devices, today announced the first US commercial use of its AXIOS Stent and Delivery System (AXIOS) at California Pacific Medical Center (CPMC) in San Francisco. The recent FDA clearance of AXIOS represents a significant breakthrough in the treatment of patients with pancreatic pseudocysts and fluid collections.
There are more than 90,000 cases of pseudocysts and pancreatic fluid collections in the US each year and the global market is estimated to be greater than $200 million annually. Prior to the FDA clearance of AXIOS last month, physicians had no "on-label" options for treating these conditions. According to Christy Foreman, director of the Office of Device Evaluation at the FDA, "the AXIOS Stent provides a new option for physicians to effectively treat pseudocysts."
AXIOS is the first stent specifically designed for treatment of a pancreatic pseudocyst or fluid collection. Its design allows for rapid drainage of these fluid collections, which are often filled with thick, infected or necrotic content.
"I'm delighted that we now have an anastomotic stent that was designed specifically for drainage of pancreatic fluid collections," said Dr. Kenneth Binmoeller, Founder and Chief Medical Officer of Xlumena. Following FDA clearance of AXIOS, Dr. Binmoeller performed the first drainage of a pancreatic pseudocyst with AXIOS at CPMC. "After AXIOS placement, we were able to clear out debris from the cyst with the endoscope, which led to immediate improvement of the patient's clinical course."
Having just closed a $25M Series C financing, Xlumena is expanding to meet the demand for AXIOS, initiating a targeted launch in selected centers of excellence across the US. AXIOS is the first in a family of devices that Xlumena plans to bring to the US market to address significant clinical needs in the field of interventional endoscopy. Already CE marked and used in rapidly growing numbers is the next-generation HOT AXIOS, which incorporates cautery into the delivery of the AXIOS stent and is currently used in Europe for the treatment of pancreatic pseudocysts, acute cholecystitis and biliary obstruction.
CAUTION: The HOT AXIOS and AXIOS devices for the gallbladder and bile duct have CE mark designation in Europe. They are not available for sale in the United States.
For more information about the AXIOS Stent and Delivery System, please visit www.xlumena.com.
About Xlumena, Inc.: Xlumena is the leader in developing products that enable advanced, image-guided endoscopy procedures. These innovations will allow endoscopists to offer minimally invasive alternatives to patients suffering from common gastrointestinal and biliary conditions. Pioneering interventional endoscopists around the world are using Xlumena's products to extend their therapeutic reach.
Video with caption: "AXIOS Stent and Delivery System Procedure Animation". Video available at: http://origin-qps.onstreammedia.com/origin/multivu_archive/PRNA/ENR/FX-SF43594-20140109-1.mp4
SOURCE Xlumena, Inc.