Regulatory FDA Panel's Divided Verdict Delays Approval for Medtronic's Blood...

FDA Panel’s Divided Verdict Delays Approval for Medtronic’s Blood Pressure Device


Medtronic’s pursuit of FDA approval for its blood pressure treatment device has encountered a notable setback as a panel of independent experts convened by the U.S. Food and Drug Administration delivered a split verdict on its potential clearance. The panel’s vote leaned against recommending approval, citing concerns regarding the equilibrium between risks and benefits inherent in the device.

This development comes in the wake of a divergent outcome involving a competing entity. The same expert panel had previously issued a favorable vote for ReCor’s device designed for a procedure termed renal denervation. This procedure targets individuals grappling with high blood pressure that defies effective control through medication alone.

When confronted with the task of balancing the merits against the drawbacks of Medtronic’s device, the results were inconclusive. Six panel members endorsed its approval, while an equal number opposed it. The ensuing deadlock necessitated the intervention of the panel’s chairperson to cast the pivotal deciding vote, ultimately leading to the device’s rejection. Interestingly, within the 13-member panel, six individuals expressed reservations about the device’s efficacy, even though they unanimously concurred on its safety.

Although the panel’s recommendations are not legally binding, they wield considerable influence over the FDA’s ultimate determinations. The panel’s inclination against greenlighting Medtronic’s device raises red flags for the company, signaling potential roadblocks in the regulatory trajectory.

Medtronic’s device exhibited the capacity to reduce blood pressure during clinical assessments but stumbled in terms of effectiveness when subjected to at-home monitoring. This dissonance is noteworthy as home monitoring is deemed a more precise reflection of a patient’s actual blood pressure status. To address this discrepancy, both Medtronic and the FDA’s evaluators advocated for supplementary data analyses. These analyses indicated that the observed variance could be attributed to various factors, including differential drug usage by patients who underwent a placebo procedure.

Jason Weidman, Medtronic’s Senior Vice President and President of the Coronary and Renal Denervation division, conveyed the company’s appreciation for the exhaustive discourse preceding the vote. Weidman’s statement underscored the company’s commitment to collaborating with the FDA to explore alternative pathways and strategies for securing potential approval for the device.

In contrast to Medtronic’s device, ReCor’s innovation, hailing from the subsidiary of Japan-based Otsuka Holdings, showcased encouraging outcomes in clinical trials, highlighting its efficacy in blood pressure reduction. Notably, the device consistently demonstrated blood pressure-lowering benefits both within clinical settings and during at-home monitoring.

Although Medtronic grapples with this recent decision’s implications, avenues for future cooperation and refinement of its blood pressure treatment device remain open, aimed at aligning with stipulated standards.

It’s imperative to acknowledge that the procedure in question, renal denervation, has traversed a tumultuous trajectory in the medical domain. Initially met with optimism and potential, earlier endeavors employing diverse devices failed to yield favorable outcomes in pivotal studies. This series of setbacks and a degree of circumspection in the devices’ development landscape culminated in the present decision. While this ruling poses challenges for Medtronic, it accentuates the FDA’s unwavering dedication to upholding stringent benchmarks in the pursuit of patient safety and overall well-being.

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