This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: AngelMed Guardian System
PMA Applicant: Angel Medical Systems, Inc.
Address: 788 Shrewsbury Avenue, Suite 2200 Tinton Falls, NJ 07724
Approval Date: April 9, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150009A.pdf
What is it? The AngelMed Guardian System is a implantable cardiac monitor intended to detect and alert patients of a potential heart attack. The Guardian System consists of three components:
- The Implantable Medical Device (IMD), which monitors the heart's electrical activity (electrograms) and alerts a patient with vibrations if it detects a potential heart attack.
- The External Device (EXD) alerts the patient of an potential heart attack with alarms and lights letting the patient know to seek medical attention. Patients must have this part of the system with them in order to be alerted.
- The programmer collects and stores information from the IMD about the patient's heart electrical activity. The doctor can use this information to determine the best treatment option. The doctor can also use the programmer to configure the adjustable settings in the IMD.
How does it work? The Guardian System monitors a patient's heart's electrical activity for changes that may indicate the heart is not getting enough oxygen and there is a potential for a heart attack. If the device detects those changes, the IMD will vibrate, and the EXD will flash light and alerts the patient to seek medical attention.
When is it used? The Guardian System is indicated for use in patients who have had prior acute coronary syndrome (ACS) events (heart attack and unstable angina) and who remain at high risk for recurrent ACS events. The Guardian System's alarm is intended to alert patients to seek medical care when there is a change in the patient's heart's electrical activity that could be indicative of a heart attack.
What will it accomplish? A Guardian System alerts patients to seek medical care when there is a change in the patient's heart rhythm that could be indicative of a potential heart attack.
When should it not be used? The IMD of the AngelMed Guardian System should not be implanted in:
- Patients with cognitive impairment that would prevent recognition of alarms
- Patients who cannot feel the vibration from the IMD
- Patients with implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy devices
- Patients where a pacemaker lead cannot be placed safely
Additional information (including warnings, precautions, and adverse events):