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EndoChoice Receives 510K Clearance for its BONASTENT(R) Esophageal and Biliary Stent Platforms



4/30/2010 12:59:12 PM

ALPHARETTA, Ga., April 29 /PRNewswire/ -- 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.

BONASTENT Esophageal

(Photo: http://www.newscom.com/cgi-bin/prnh/20100429/NY95943 )

About EndoChoice, Inc.

EndoChoice designs, manufactures and markets innovative solutions for professionals in gastrointestinal endoscopy worldwide. Its diverse portfolio of high-quality equipment, devices, supplies and services uniquely positions EndoChoice as a leading resource for GI professionals. The company strives to exceed its customers' expectations through its superior products, exemplary customer care, knowledgeable sales force, and easy online ordering. For more information, visit www.EndoChoice.com.


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