Early Feasibility Studies for Devices: FDA Highlights Success From Pilot

Regulatory NewsRegulatory News | 30 August 2017 |  By 

In a paper published in the Journal of Vascular and Interventional Radiology last week, two officials from the US Food and Drug Administration (FDA) say that the agency's early feasibility study (EFS) program helped optimize the development of a new type of catheter designed to prevent pulmonary embolisms.

The program is part of an effort by FDA to promote more EFSs being done in the US, as device makers often conduct such studies elsewhere before conducting later studies in the US.

Around the same time as the paper was published, FDA also updated its website to provide clarification about the program, including information on what devices are appropriate and instructions for how to submit an application to the program.

Angel Catheter

According to two officials, Andrew Farb and Jose Pablo Morales, both medical officers at the Division of Cardiovascular Devices within the Center for Devices and Radiological Health (CDRH), by participating in FDA's EFS pilot, Bio2 Medical was able to bypass conducting a traditional feasibility study and shave months off its pivotal study for its Angel Catheter.

The Angel Catheter—one of nine devices chosen to participate in the pilot—combines the functionality of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter to prevent pulmonary embolisms while providing access to the central venous system in patients that are contraindicated to standard anticoagulation treatment.

"This device example shows that the US EFS pathway can be beneficial for medical device manufacturers and provides US patients with the opportunity for treatment using novel devices," Farb and Morales write, echoing statements made by CDRH Director Jeff Shuren in June.

While participation in the pilot lead to some early delays—FDA required the company to conduct additional imaging in the EFS, which led to a 10-month delay between a go-ahead for the study and enrollment—Farb and Morales say the additional imaging provided greater safety information that ultimately allowed for a more efficient pivotal trial.

In a press release in June announcing the results of the pivotal trial, Bio2 Medical CEO Christopher Banas said the company's participation in the EFS pilot contributed to the "study being completed nine months ahead of schedule due to its fast enrollment."

Journal, FDA EFS Program


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