Business Wire06.02.17
GI Dynamics Inc. has received notification from its notified body SGS United Kingdom Limited (SGS) that the CE Mark for its EndoBarrier system has been suspended pending closure of nonconformances related to its quality management system required under ISO 13485:2003 and 93/42/EEC.
“This action does not call the safety and efficacy of EndoBarrier into question and this action does not constitute a recall,” said Scott Schorer, CEO and president. “We are working swiftly to address issues within our quality management system that were detailed in a corrective action report from SGS; we will have these nonconformances resolved and have our CE Mark reinstated as quickly as possible.”
Since the new management team at GI Dynamics assumed leadership last spring, the company has been working diligently to address these and other issues. The company has shipped what it believes will be sufficient inventory to its customers to ensure uninterrupted service during the suspension. In addition, all implanted patients may continue treatment subject to normal ongoing evaluation and monitoring by their healthcare professional.
Specific plans and actions have been initiated to address the nonconformances identified by SGS.
“We hired a chief compliance officer with experience in these matters as well as quality and regulatory experts to help us address the issues while maintaining compliant surveillance and vigilance,” Schorer said. “We have made significant progress over the past year and are focused on continuous improvement to the quality management system. We are committed to ensuring EndoBarrier is available for our patients and clinicians.”
GI Dynamics Inc. is the developer of EndoBarrier, the first endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only in the United States. Founded in 2003, GI Dynamics is headquartered in Boston, Mass.
“This action does not call the safety and efficacy of EndoBarrier into question and this action does not constitute a recall,” said Scott Schorer, CEO and president. “We are working swiftly to address issues within our quality management system that were detailed in a corrective action report from SGS; we will have these nonconformances resolved and have our CE Mark reinstated as quickly as possible.”
Since the new management team at GI Dynamics assumed leadership last spring, the company has been working diligently to address these and other issues. The company has shipped what it believes will be sufficient inventory to its customers to ensure uninterrupted service during the suspension. In addition, all implanted patients may continue treatment subject to normal ongoing evaluation and monitoring by their healthcare professional.
Specific plans and actions have been initiated to address the nonconformances identified by SGS.
“We hired a chief compliance officer with experience in these matters as well as quality and regulatory experts to help us address the issues while maintaining compliant surveillance and vigilance,” Schorer said. “We have made significant progress over the past year and are focused on continuous improvement to the quality management system. We are committed to ensuring EndoBarrier is available for our patients and clinicians.”
GI Dynamics Inc. is the developer of EndoBarrier, the first endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only in the United States. Founded in 2003, GI Dynamics is headquartered in Boston, Mass.