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How to run a successful clinical trial for embolic protection devices

Friday, December 1, 2017

Because of the surge in the use of embolic protection devices (EPDs), the market for these devices is expected to grow into a billion-dollar industry. EPDs may protect patients from serious neurological damage that could occur during transcatheter aortic valve replacement (TAVR) procedures; they are designed to catch or divert valve debris that may travel to the brain. EPDs are commercially available in Europe, and the FDA cleared an EPD for the first time last June.

Despite their potential, EPD trials have shown mixed success. To compete in the growing TAVR market, EPD manufacturers must consider three factors to maximize their chances for trial success.

First, principal investigators will need to collect comprehensive patient health histories. This includes measuring the extent of their patients’ illnesses, while accounting for factors that can cause attrition and introduce risk to a trial’s viability. Investigators would, for example, ensure their patients’ conditions are stable for at least 30 days prior to study enrollment.

Second, manufacturers should select trial sites based on their commitment and proven ability to dedicate significant time and resources to the study—more than is expected with a traditional device trial. We recommend building multidisciplinary investigative teams, including not only a heart failure/valve cardiologist, an interventional cardiologist, cardiovascular surgeons and imaging specialists, but also geriatricians, stroke neurologists, electrophysiologists, anesthesiologists and behavioral specialists.

Third, investigators must standardize their definitions of stroke and their criteria for diagnosing neurological complications. These standards should fall within existing and anticipated regulatory guidelines to streamline approval and adoption by payers.

For the EPD market to grow as anticipated, manufacturers must design their trials to more clearly demonstrate the effectiveness and safety of their devices. The strategies mentioned here will help manufacturers design better trials with more elucidating results that can help them develop EPDs more successfully.


Guest Contributor David Novotny is Senior Vice President of the Medical Device & Diagnostics Division at Novella Clinical, overseeing the Cardiovascular Therapies delivery and strategy unit. He has nearly 20 years of clinical research experience in CRO, medical device, biopharmaceutical, and hospital environments. Mr. Novotny is responsible for the oversight, strategy and operational success of all medical device and diagnostics sponsor programs across the globe, including clinical execution and governance management. For more information, visit novellaclinical.com/mdd.

This article was reprinted from Volume 24, Issue 12, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>

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