The European Society of Gastrointestinal Endoscopy (ESGE) in the upcoming May issue of Endoscopy, the official journal of the ESGE, is preparing to publish a set of guidelines on clinical utility and selection process of patients for colon capsule endoscopy. These guidelines will have a direct effect on applicability and maybe wider use of PillCam COLON 2, a product of Israel-based Given Imaging. It should be noted that PillCam COLON 2 has been approved by the European regulators, but was rejected by the FDA in the United States in 2008 on the grounds of “not substantially equivalent”.
Homi Shamir, president and CEO of Given Imaging, released the following statement about upcoming guidelines:
“Many patients who should be screened are non-compliant due to a variety of reasons and we believe PillCam COLON 2 offers an important new option, providing the optimal balance of low risk, convenience and high diagnostic accuracy… We are very pleased with the publication of ESGE colon capsule endoscopy guidelines which will support our efforts to educate physicians regarding the clinical utility and benefit of using PillCam COLON for certain patients for whom colonoscopy might be risky including: patients taking blood thinning medications, patients with a higher risk of cardiopulmonary events during or after sedation, or those at risk of perforation. We continue to see the role of PillCam COLON expand and these guidelines will help support the broader launch of this product in Europe this year…”
Product page: PillCam COLON 2 capsule endoscopy …