(Source: Reuters) On August 23, On Wednesday, the independent experts working for the United States Food and Drug Administration (FDA) narrowly voted against recommending the clearance of a blood pressure therapy device manufactured by Medtronic (MDT.N), stating that the risks associated with using the device do not exceed the benefits.
On Tuesday, the same council gave its approval for a competing company’s gadget to be used in a procedure known as renal denervation. This procedure is performed on patients whose hypertension cannot be treated with medication.
When asked if the advantages of the tool outweighed the potential drawbacks, six of the members voted in favor of it, while the seventh member chose to remain neutral. After that, the panel’s chair had to cast the deciding vote against the gadget in order to break the tie.
Separately, while all of the panelists agreed that the device could be used without risk, six of the thirteen members disagreed that it was effective.
The recommendations made by the group are not legally binding, but the FDA typically acts in accordance with them.
“We appreciate the robust conversation that occurred prior to the vote,” Jason Weidman, senior vice president and president of Medtronic’s Coronary and Renal Denervation business, said in a statement. He also added that the company will continue to engage with the FDA in order to offer a new option to the market.
In clinical tests, the gadget developed by Otsuka Holdings (4578.T), which is based in Japan, and its subsidiary ReCor was proved to be effective in decreasing blood pressure. At the doctor’s office, where the patient’s blood pressure was being monitored more accurately than at home, the device manufactured by Medtronic was successful in bringing down the patient’s blood pressure.
Before the hearing, both Medtronic and the staff reviewers of the FDA stated that additional analyses of the data showed that the difference could be due to factors such as the use of more medicines by patients treated with a “sham” surgery. This was stated before the meeting.
The company was trying to get the gadget approved by the health regulator so that it could be sold to patients whose hypertension, often known as high blood pressure, cannot be controlled by medication.
Initial trials of older devices used in the treatment failed important studies, and several companies backed out of the race to find replacements for them. As a result, the surgery, which is legal in Europe and other parts of the world, is not approved in the United States. This is because of the reasons stated above.
