CDRH EFS Program is Working: Study
Two CDRH Division of Cardiovascular Devices staffers say the Center’s early feasibility study (EFS) program worked well for the Bio2 Medical Angel Catheter, which was one of the studies included in the EFS pilot. Writing in the Journal of Vascular Interventional Radiology, the two say an EFS is a limited clinical investigation to evaluate the device design concept for initial clinical safety and device functionality in a small number of subjects. “These studies are useful when further information on device function and safety cannot practically be obtained through additional nonclinical assessments or when appropriate nonclinical tests are unavailable,” they say.
A key element in a 10/1/13 EFS guidance is that IDE approval of an EFS may be based on less nonclinical data than would be needed to support initiation of a larger clinical study of a more finalized device design. “This approach takes into account the underlying clinical condition; the appropriate use of leveraged information from device prototypes; and the availability, benefits, and risks of alternative treatments,” the authors write. “To increase patient protection, an EFS incorporates enhanced clinical risk mitigation strategies.”
The authors say that additional imaging required for the Angel Catheter EFS to help ensure patient safety led to a 10-month delay. Ultimately, the agency, the sponsor, and the investigator agreed that the imaging did not add sufficient value to warrant inclusion in a larger clinical study of the catheter. But doing the imaging in the EFS gave the sponsor and FDA additional safety information and enabled design of a more efficient pivotal trial.
Knowledge gained during the EFS also was the basis for a modification to the length of the cather’s hydrophilic coating. The authors say the change was made in a timely manner during the EFS and was incorporated into the final device design for the pivotal trial.
“This device example shows that the EFS pathway can be beneficial for medical device manufacturers and provides U.S. patients with the opportunity for treatment using novel devices,” the authors conclude…. “Although adoption of an early interaction approach can seem to lengthen the timeline, the reward should be an overall more direct, predictable, and efficient device development plan, which increases the likelihood of a successful marketing application….The CDRH EFS program is currently in its growth phase with yearly increases in the number of IDE submissions and approvals. Continued progress in this area will help restore the United States to a leadership position in the clinical evaluation of novel devices, and increase access of U.S. patients to potentially beneficial products.”