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New upper GI EMR device enters market, postmarket study in BE underway
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Boston Scientific announced it has launched the Captivator, a new device designed for endoscopic mucosal resection of the upper GI tract, which enables better visualization, control and easy passage of devices, according to a press release.
The company also announced it initiated a prospective postmarket registry for studying the device’s performance in resecting early neoplasia in Barrett’s esophagus, which will evaluate endoscopic mucosal resection (EMR) success, procedure time, acquired tissue quality and complications in about 300 patients at 16 clinical centers across eight countries, with results expected in 2016.
“The Captivator EMR Device provides improved endoscopic visualization, so the resection can be better directed to the area of interest,” Jacques Bergman, MD, PhD, professor of gastrointestinal endoscopy at University of Amsterdam, the Netherlands, and lead investigator of the global registry, said in the press release. “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 device enables more complete visualization with an unobstructed 360-degree peripheral view and quick management of complications with the ability to use accessories with the device during EMR, according to the press release. It is also the only EMR device that includes a pathology kit.
“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,” David Pierce, senior vice president and president, endoscopy, Boston Scientific, said in the press release. “The Captivator EMR Device provides physicians and patients with an important new option for staging and treating early esophageal neoplasia and cancer.”
The device is currently available in the U.S., Europe, Singapore, Australia and Puerto Rico, according to the press release.
Disclosures: Bergman reports he is the lead investigator of Boston Scientific’s Captivator EMR device global registry. Pierce reports he is an employee of Boston Scientific.