EndoChoice, a designer, manufacturer and marketer of solutions in gastrointestinal endoscopy, has received 510(k) clearance from FDA to market 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.
EndoChoice said that 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 Hook & Cross wire geometry provides segmental compression, reducing stent migration typically experienced with other metal stent platforms.
Peter Stevens, director of endoscopy at New York Presbyterian Hospital/Columbia University Medical Center, said: “I have been very pleased with my placements of the Bonastent. It has performed beautifully and I look forward to incorporating future EndoChoice Bonastent platforms into my practice.”
Mark Gilreath, founder and CEO of EndoChoice, said: “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. We are pleased to have such a successful product launch in the US and Europe. Patients can now benefit from the unique feature of segmental compression, only offered in the Bonastent platform technology.”
The Bonastent platform is expected to be available for hands-on demonstration at the 2010 Digestive Disease Week conference, which is being held in New Orleans.