FDA Approves Implant for Detecting Oncoming Heart Attacks

Frank
September 5, 2018
33 Views

Angel Medical Systems, based in Tinton Falls, New Jersey, won FDA approval for its AngelMed Guardian implantable device that may help detect oncoming heart attacks before they even happen. It looks like a pacemaker and it monitors for ST segment changes, an ECG sign of ischemia.

When it detects sustained ST segment changes, the implant sends a signal to an external device that then warns the patient to seek medical care. The hope is that early detection will lead to many heart attacks avoided, or at least whose effects would be minimized by earlier attention from trained clinicians.

“The Guardian device fills an unmet medical need by providing more effective diagnosis of a life-threatening condition when compared to patient symptoms alone. The Guardian provides this adjunctive benefit without increasing the rate of false positives and may in fact reduce that rate. A very important capability of the Guardian is that in the absence of symptoms, it may identify ACS events, including heart attacks, and prompt the patient to seek medical attention.” in a published statement said Angel Medical System’s Chief Executive Officer, Dr. David R. Fischell.

Product page: AngelMed Guardian…

Via: Angel Medical…

Frank’s source: https://www.medgadget.com/2018/04/fda-approves-implant-for-detecting-oncoming-heart-attacks.html

 

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