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You are here: Home / Nerac Insights / Case Studies / Business Development / EU Regulatory Compliance

EU Regulatory Compliance

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Issue:

The client, a major cardiovascular stent company, wanted to ensure proactively that their intra-aortic balloon pump (IABP) catheters would comply with new EU regulations.

Analyst Approach:

The Nerac team reviewed over 1,000 publications to identify pertinent clinical research. A meta-analysis was performed on 260 applicable articles.

Client Benefit:

The analysis validated the efficacy of IABP catheters for certain indications and built a case for IABP catheters as a preferred treatment approach. In addition, the analysis identified indications where literature evidence was insufficient and clinical trials would be needed to comply with future regulations. Finally, the analysis provided material for publications on the best treatment techniques.

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