November 3, 2020

Study Shows Use of VQI Registry Data to Support FDA Decisions Yields a High Return on Investment

November 3, 2020—Findings from a study conducted to determine the potential value (cost-saving, time-saving, and return on investment) created by device evaluation studies using the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry infrastructure were published by Jack L. Cronenwett, MD, et al online in the open-access BMJ Surgery, Interventions, & Health Technologies.

Gregory Pappas, MD, from the FDA’s Center for Biologics Evaluation and Research, is Senior Investigator of the study. Dr. Cronenwett is Emeritus Professor of Surgery at Geisel School of Medicine and The Dartmouth Institute for Health Care Policy and Clinical Practice at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire. The study investigators represent a diverse team of academicians, FDA regulators, and device manufacturers, noted Dr. Cronenwett in correspondence with Endovascular Today.

According to the investigators, postapproval device evaluation using real-world data from registries can be done much more economically and faster than traditional independent industry studies. The findings show that more efficient, total product lifecycle device evaluation is much more feasible by using real-world data from coordinated registry networks, which should allow better device selection for specific patients and result in better outcomes.

As summarized in the study abstract, the investigators compared studies that used data from the VQI registry with estimated costs of independent industry studies (counterfactual studies) using an established model with design specifications determined by FDA reviewers. They noted that real-world data from the VQI registry has been used to support FDA regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent industry studies that would otherwise have been conducted to support regulatory decisions.

The investigators analyzed the initial six studies evaluating vascular devices for regulatory decisions using data from the VQI registry that generated evidence for four device manufacturers.

The investigators reported in the journal that the return on investment for these studies was estimated to be 143%, with estimated cost savings of 59% based on an actual per-patient (with 5-year follow-up) cost of $11,000 using VQI data versus $26,000 from the counterfactual when averaged across all studies. Significant enrollment time-savings (45% to 71%) were also realized compared with industry-based estimates.

In BMJ Surgery, Interventions, & Health Technologies, the investigators concluded, “The use of real-world data from the VQI registry in this study and the transcatheter valve treatment coordinated registry network in a prior study indicates that substantial value was added to device evaluation projects by the reuse of registry data, with additional potential savings if linked claims data can be used instead of costly long-term in-person follow-up.”

Dr. Cronenwett and Dr. Pappas discussed the study’s findings with Endovascular Today.

“Postapproval device evaluation using traditional methodology is limited by high cost and lengthy time requirements,” commented Dr. Cronenwett to Endovascular Today. “Registries that already collect device-related outcomes can solve this problem by providing cost-effective data that are needed for refining indications and improving patient selection.”

Dr. Pappas stated, “This study and our prior analysis of transcatheter valve evaluation using registry data underscore the substantial cost- and time-saving that can accrue with this approach. Real-world data from registries like VQI are increasingly valuable to manufacturers, FDA, and patients for optimal device evaluation.”


November 6, 2020

Safety and Efficacy of LimFlow’s pDVA System Evaluated in PROMISE I Trial

November 2, 2020

Boston Scientific's Ranger DCB Receives FDA Approval