Connecticut residents go to doctors and use medical technology every day. A medical device should never be given to a patient unless it is meticulously examined. When a medical device manufacturer or pharmaceutical company fails to make a safe drug or device, injuries and even death can occur.
It was reported that multiple U.S. and European heart physicians are requesting a delay regarding using a medical device to reduce blood pressure by blasting kidney arteries after a failure in the clinical trial of the technology. Trial details that were recently presented at a medical meeting showed that the device failed to reduce blood pressure any more than a placebo procedure in a 364-patient study.
This data of the trial questioned the therapy, known as renal denervation, that has been approved in more than 80 countries. Doctors were hopeful that the therapy could be a new way to treat high blood pressure for patients who are not helped enough from drugs. The devices in question, however, are not approved in the United States. Although, it was was reported that various U.S. medical companies and institutions do believe in the technique and the device.
Early use of a new medical device by a doctor carries with it some degree of medical malpractice liability risk. The company that manufactures the device explained that the trial did not prove that the procedure does not work. Officials said that the company will continue to study the device’s capability and sell the device in countries where it is approved.
Even though all medical devices have to go through an approval process, there are some medical devices that have ended up causing harm to people that used them.
Source: The Huffington Post, “Heart Doctors Seek Curbs On Renal Denervation Devices” Ransdell Pierson and Bill Berkrot, Apr. 09, 2014