Press Release Summary:
Offering minimally invasive alternative to esophagectomy,Â Captivator™ EMR Device for Endoscopic Mucosal Resection enables staging and removal of precancerous tissue and early esophageal cancer in upper GI tract during endoscopic outpatient procedure. Device provides physicians with 360Â° unobstructed peripheral view for complete visualization of diseased area. Pathology kit is included to provide added convenience for endoscopists and pathologists.
Original Press Release:
Boston Scientific Launches the Captivator(TM) EMR Device to Treat Diseases of the Upper GI Tract
MARLBOROUGH, Mass., – Boston Scientific Corporation (NYSE: BSX) announced today the launch of the Captivator™ EMR Device for Endoscopic Mucosal Resection (EMR), a minimally invasive alternative to an esophagectomy, a surgical procedure that removes part of the esophagus in upper gastrointestinal (GI) tract cases. EMR enables staging and removal of precancerous tissue and early esophageal cancer in the upper GI tract during an endoscopic outpatient procedure. The Captivator EMR Device is specifically designed for upper GI EMR and provides physicians with enhanced visualization, control and easy passage of devices.
A common precursor to esophageal cancer is Barrett's Esophagus, which is a complication of acid reflux disease that causes abnormal changes to the lining of the esophagus. More than 900,000 people worldwide are diagnosed with Barrett's Esophagus[1. Nearly 10 percent of patients with chronic heartburn develop Barrett's Esophagus and endoscopic management may help reduce the potential for an esophagectomy, a more invasive and costly surgery.[2,[3
The company also enrolled the first patient in a multi-center, prospective, post-market registry initiated to study the performance of the Captivator EMR Device for endoscopic resection of abnormal tissue growth known as early neoplasia, specifically in Barrett's Esophagus. It will document procedural success, procedure time, quality of acquired tissue for histopatholgy, and procedural complications. The registry will enroll approximately 300 patients at 16 clinical centers in eight countries, and is expected to be completed in 2016.
"The Captivator EMR Device provides improved endoscopic visualization, so the resection can be better directed to the area of interest," said Dr. Jacques Bergman, professor of Gastrointestinal Endoscopy at University of Amsterdam, the Netherlands, and lead investigator of the global registry. "The enhanced view, along with easy passage of accessory devices and the ability to use compatible hemostatic devices to manage potential bleeding and complications may enable a safer endoscopic resection."
The Captivator EMR Device provides physicians with a 360 degree unobstructed peripheral view for more complete visualization of the diseased area when performing resections. And unlike other EMR devices, accessory devices such as the Boston Scientific Resolution™ Clip and Interject™ Needle can be used with the device during the procedure to manage potential complications quickly. The Captivator EMR Device is also currently the only EMR device that includes a pathology kit to provide added convenience for endoscopists and pathologists.
"As a leader in GI endoscopic devices, this launch complements our existing product offering for lower GI EMR procedures, and expands our portfolio into the growing upper GI EMR segment ," said David Pierce, senior vice president and president, Endoscopy, Boston Scientific. "The Captivator EMR Device provides physicians and patients with an important new option for staging and treating early esophageal neoplasia and cancer."
The Captivator EMR Device is available in the United States, Europe, Singapore, Australia and Puerto Rico.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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Boston Scientific Corporation
[3 Datasource: Medicare's MedPar 2012 and Medicare's OPPS 2012 (Outpatient Prospective Payment System) files