Medtronic Resolves Issues with FDA

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Medtronic Resolves Issues with FDA

On Wednesday Medtronic Inc. announced that the issues highlighted in the two warning letters from the Food and Drug Administration regarding their facilities in Mounds View and Juncos, Puerto Rico have been resolved. The resolution of these issues means that critical medical devices produced in these plants can now be made ready for introduction into the United States market. “We are optimistic approvals are imminent”, said Medtronic spokesman Brian Henry.

Medtronic believes that the FDA will approve its heart defibrillator called Protecta that minimizes improper shocks in people. Tao Levy, a Collins Stewart analyst said this device could have a “premium price” when launched which could stabilize the pricing for the devices and benefit other companies that produce implantable defibrillators.

They also want to introduce a device for fecal incontinence called InterStim therapy. The device sends electric pulses to the sacral nerve to help control bowel movements. A similar device has already been approved in the United States for urinary incontinence, and this specific device has been available outside the US since the year 2000. This will help the 5.5 million or more Americans with this condition, and one financial analyst estimated that the market for InterStim could reach $300 million.

I think it’s great that these devices could potentially be infused into the US medical market sometime soon. They will undoubtedly prove helpful and beneficial in the lives of millions of individuals with either life-threatening or embarrassing medical conditions that restrict their quality of life. Even though it’s a little disappointing that we had to go without the availability of these devices for so long, I think it’s good that the Food and Drug Administration is looking out for our well-being by not approving medical products produced in facilities they have issues with.

Everyone’s talking about these devices like the approval has already happened and stock in Medtronic has already gone up. While it’s true that the FDA’s advisory panel have already recommended that the devices be approved, no one really knows if and when the approval by the FDA itself will actually happen. Until we know more about the situation and the FDA’s approval or disapproval, no final statements or opinions can be formed regarding the use of these devices in the United States.


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