Endologix Provides Japanese Regulatory Update

Endologix announced that the expert panel for the Pharmaceutical and Medical Devices Agency of the Japanese Ministry of Health, Labour and Welfare has declined Shonin approval of the company's PowerWeb endoluminal stent graft due to the original Japanese clinical trial design and execution. The decision was not the result of clinical issues with the Endologix PowerWeb device or patient outcomes from the Japanese clinical trial. The expert panel has requested that Endologix submit its Powerlink System for Shonin approval using its existing U.S. clinical trial data.

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