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.
The Nerac team reviewed over 1,000 publications to identify pertinent clinical research. A meta-analysis was performed on 260 applicable articles.
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.
- Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond77By Ron Sills, Nerac Analyst, and Donna Mitchell-Magaldi, Nerac Analyst Originally Published: September 26th, 2014 In 2009, the European Commission released MedDev 2.7.1 Rev.3 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” as a supplement to the requirements of the EU Medical Device Directive 93/42/EEC. In order for medical devices to be marketed in…
- 76By Roz Sweeney, Ph.D. Nerac Analyst, Uses of Clinical Literature Evaluations Comprehensive evaluations of the clinical and technical literature serve a variety of purposes for medical device companies. Literature evaluations are frequently used in the following ways: To support design of clinical investigations (e.g. to understand expected outcomes and results for historical controls). To support regulatory…
- 63By Donna Mitchell-Magaldi, Nerac Analyst Originally Published: February 10, 2015 It is no surprise to anyone in the medical device industry that the European Commission is working on a new regulatory framework that will in essence take the three existing directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/42 regarding medical devices, and Directive…