AIM: Device preapproval reform needed--insights from Watchman

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Regulatory reforms are necessary to improve the evidentiary standard for device evaluation and approval, according to the authors of a commentary published online July 11 in the Archives of Internal Medicine.

Eugenio H. Cingolani, MD, and colleagues from Cedars-Sinai Medical Center in Los Angeles opined that the medical device approval process is less rigorous than the process for approving new drugs, and reforms should be made to ensure device safety and effectiveness. Among goals noted in the commentary, the authors aimed to review the basis for device approval, review the FDA decision to not approve the Watchman left atrial appendage closure device (Atritech, being acquired by Boston Scientific) and propose better standards for regulatory policy.

The Watchman device is used for patients with nonvalvular atrial fibrillation at risk of stroke and eligible for anticoagulation therapy. Based on several factors, the authors argued the FDA decision for nonapproval of the Watchman device was justified.

“Important insights gained from the Watchman experience are utilized to instantiate a proposal for greater rigor, clarity, efficiency and transparency in device evaluation, approval and surveillance,” Cingolani et al wrote. “The nonapproval decision by the FDA and its request for additional studies clarifying the procedural safety and durability of efficacy for its intended use appear well justified.”

The writers argued that the data standards sufficient to support approval of a medical device would not be sufficient to support the approval of a drug that treats the same condition.

With regards to the approval process, Cingolani and colleagues recommended making it more transparent; conducting larger and longer preapproval randomized controlled trials; and including a broad spectrum of patients representative of those most likely to use the device.

Reforms to the surveillance process and operational standards were recommended as well. They encouraged mandatory reporting of the detailed specification of installed devices to enable systematic assessment, notification or recall; stringent surveillance through registries; and greater authority to conduct postapproval trials.

"Greater attention to optimal trial design, appropriate patient population, choice of end points, sufficient number of events, duration of follow-up, and other elements of supporting trials (as illustrated by the Watchman example) is warranted to enhance the strength of the preapprvoal process," concluded the authors.