Given Submits PillCam COLON 2 Application to FDA

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YOQNEAM, Israel―Given Imaging, a pioneer of capsule endoscopy, today announced that it has filed a U.S. Food and Drug Administration (FDA) application seeking regulatory clearance to market its PillCam COLON 2 for visualization of the lower gastrointestinal tract.

"Filing for FDA clearance is another important milestone for Given Imaging in advancing our efforts to commercialize PillCam COLON 2," said Homi Shamir, president and CEO, Given Imaging. "We believe that PillCam COLON 2 meets a significant unmet need for a non-invasive imaging tool for visualization of the lower GI Tract for physicians and their patients who are unable to undergo colonoscopy or in cases of an incomplete colonoscopy."

The PillCam COLON 2 capsule endoscopy system is complementary to colonoscopy and the proposed indication for use meets an unmet need and makes it an attractive imaging tool for patients who are at a higher risk for complications from colonoscopy as well as for patients who received an incomplete optical colonoscopy. The diagnostic use of PillCam COLON 2 may improve the standard of care for patients who are currently unable to undergo an exam, while minimizing potential adverse events, and reducing the risks associated with radiation-based alternative procedures such as CT colonography or double-contrast barium enema.

Based on guidance provided by the FDA, Given Imaging has submitted its PillCam COLON 2 application through a direct de novo pathway. Under new guidelines specified by the FDA Safety and Innovation Act (FDASIA) of 2012, the Company believes that the direct de novo pathway may expedite the regulatory approval process by a few months.

The PillCam COLON 2 capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source. PillCam COLON 2 is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID® software to compile the video data and enable the physician to review and report the results of the PillCam study.

The risks of PillCam capsule endoscopy include capsule retention, aspiration, or skin irritation. PillCam COLON capsule endoscopy presents additional risks, including risks associated with drug products used to prepare the patient for the procedure, which are currently used for colonoscopy, including allergies or other known contraindications to any preparation agents or medications used for the PillCam COLON regimen, according to laxative medication labeling and per physician discretion.

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