EndoChoice granted FDA marketing clearance for BONASTENT Esophageal and Biliary Stent platforms

Apr 30 2010

EndoChoice, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its BONASTENT® Fully Covered Esophageal Stent for the treatment of malignant esophageal obstructions, and its BONASTENT Uncovered Biliary Stent for the treatment of malignant biliary obstructions.

With over 8,000 placements worldwide, the BONASTENT platform has provided physicians treating malignant strictures in the GI tract increased clinical performance attributed to its revolutionary "Hook & Cross" wire geometry. The BONASTENT's proprietary Hook & Cross wire geometry provides segmental compression, reducing stent migration typically experienced with other metal stent platforms.  

"I have been very pleased with my placements of the BONASTENT," said Peter Stevens, M.D., Director of Endoscopy at New York Presbyterian Hospital/Columbia University Medical Center in New York. "It has performed beautifully and I look forward to incorporating future EndoChoice BONASTENT platforms into my practice."

"This revolutionary line of metal stents will make a tremendous impact improving the quality of life for the tens of thousands of patients suffering from GI cancers," said Mark Gilreath, Founder and CEO of EndoChoice.  "We are pleased to have such a successful product launch in the United States and Europe.  Patients can now benefit from the unique feature of segmental compression, only offered in the BONASTENT platform technology."

The BONASTENT platform will be available for hands-on demonstration at the 2010 Digestive Disease Week conference, which is being held in New Orleans on May 2nd through 5th.