The U.S. Food and Drug Administration (FDA) expert panel has voted against the approval of Medtronic’s blood pressure treatment device, as independent experts expressed concerns that the risks associated with the device outweighed its potential benefits. This decision comes in the wake of a contrasting vote favoring a rival device developed by ReCor for use in a surgical procedure known as renal denervation, intended for patients whose high blood pressure remains uncontrolled despite medication.
During the assessment of Medtronic’s device, a divided opinion emerged among the panel members regarding the balance between benefits and risks. Six members voted both for and against the device, and one abstained, leading to a tie that was ultimately broken by the chairperson of the panel, resulting in a vote against the device’s recommendation. Another aspect of the panel’s assessment centered on the device’s safety, where all members agreed on its safety, but six out of thirteen-panel members expressed reservations about its effectiveness.
Although the panel’s recommendations are not binding, they usually influence the FDA’s decisions. Medtronic’s senior vice president and president of the Coronary and Renal Denervation business, Jason Weidman, acknowledged the thorough discussions that took place before the vote and expressed the company’s commitment to collaborating with the FDA to introduce a new treatment option.
In contrast to Medtronic’s device, a device developed by Japan-based Otsuka Holdings’ unit ReCor demonstrated a positive impact on lowering blood pressure in clinical trials. Medtronic’s device exhibited the ability to lower blood pressure during medical appointments, but not when monitored at home, which is considered a more accurate reflection of blood pressure levels.
Medtronic, along with FDA staff reviewers, highlighted that additional data analyses indicated that the observed differences might be attributed to factors such as patients treated with a “sham” procedure using more medications. Medtronic had sought FDA approval for its device to be used in patients with hypertension (high blood pressure) that remain unmanageable with conventional drug treatments.
It’s important to note that the surgery involving these devices, known as renal denervation, is permitted in various parts of the world including Europe, but has not received approval in the U.S. due to previous unsuccessful outcomes of studies involving older versions of these devices. The discontinuation of development efforts by several companies further contributed to the lack of progress in gaining approval for this procedure in the U.S.