(CTN News) – On Wednesday, the independent specialists of the U.S. Food and Drug Administration (FDA) narrowly decided not to advise the approval of Medtronic’s (MDT.N) device designed for treating blood pressure.
Their reasoning was that the potential risks associated with its use are not justified by the benefits it offers.
Interestingly, the very same panel had given its approval on Tuesday for a competing device developed by ReCor.
This device is intended for a medical procedure known as renal denervation, specifically for patients with unmanageable high blood pressure that doesn’t respond to medication.
FDA Divided Opinions and Deliberations: Panel Votes Against Device Approval Despite Split Outcome
In the midst of discussions about whether the benefits of the device outweighed its risks, the voting outcome revealed a divided opinion among the panel members.
Six members cast their votes in favor of the device, while an equal number voted against it.
One panel member chose to abstain from voting. Consequently, it fell upon the chairperson to make the final call, which resulted in a vote against the device’s approval.
On a separate note, although all the panel members agreed that the device was safe for use, a notable split emerged when it came to its effectiveness. Among the thirteen members, six voted against the device’s efficacy.
It’s important to note that while the recommendations put forth by the panel are not legally binding, they typically hold significant weight and are often followed by the FDA in its decision-making process.
In response to the proceedings, Jason Weidman, the Senior Vice President and President of the Coronary and Renal Denervation business at Medtronic, expressed gratitude for the thorough deliberations leading up to the vote.
Weidman stated through a press release that the company would continue its collaboration with the FDA to introduce a novel treatment option.
Contrasting Outcomes in Clinical Trials: ReCor’s Effective Blood Pressure Reduction vs. Medtronic’s Discrepancies
The device developed by ReCor, a subsidiary of Japan-based Otsuka Holdings (4578.T), exhibited positive outcomes in clinical trials by effectively reducing blood pressure.
In contrast, Medtronic’s device demonstrated blood pressure reduction only within the clinical environment, failing to replicate the same results when patients monitored their blood pressure at home—a more accurate measure.
Both Medtronic and the FDA’s staff reviewers mentioned prior to the meeting that additional data analysis revealed the discrepancy could be attributed to factors like the utilization of more medications by patients who underwent a “sham” procedure.
The company sought approval from the health regulatory body for a device designed for patients whose hypertension (high blood pressure) remains unmanageable through medications.
Although this procedure is permitted in Europe and other parts of the world, it has not gained approval in the United States.
Earlier studies involving older devices used in similar procedures did not yield successful outcomes, leading to several companies withdrawing from the development race.