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The US Food and Drug Administration’s (FDA) advisory panel has recently rendered contrasting decisions on the approval of blood pressure treatment devices. Medtronic’s device faced skepticism as the panel narrowly voted against recommending its approval, citing an unfavorable risk-benefit balance. This comes in the wake of the same panel giving a nod to a competing device developed by ReCor for a surgical procedure known as renal denervation, aimed at patients with uncontrolled high blood pressure.
The FDA panel’s verdict, though not binding, usually influences the regulatory agency’s decision. While the Medtronic device generated a split vote on its benefits and risks, with a tie-breaking vote against it, six out of thirteen members found its effectiveness questionable.
Medtronic expressed gratitude for the deliberations and pledged to work alongside the FDA for alternative options. In contrast, ReCor’s device exhibited success in reducing blood pressure during clinical trials, suggesting a promising solution for hypertension management.
Interestingly, the outcomes were accompanied by a disparity in blood pressure monitoring locations. ReCor’s device demonstrated blood pressure reduction both in clinical settings and at home, while Medtronic’s showed effectiveness solely in clinical environments.
Medtronic’s device was designed for patients with drug-resistant hypertension, where conventional medications fail to control blood pressure. Despite the panel’s verdict, the company and FDA reviewers highlighted the potential influence of factors like medication usage in driving the outcomes.
The contrasting decisions underscore the complexities of evaluating medical devices’ benefits and risks, offering insights into the intricate landscape of medical technology approvals.