Angel Medical Systems (AngelMed) has announced the first commercial implantation and US launch of its The Guardian device. The procedure marks the Guardian’s first use following its recent US Food and Drug Administration (FDA) approval. Indicated for acute coronary syndrome (ACS) events, including silent heart attacks, the Guardian system is described by AngelMed as the first implantable cardiac detection monitor and patient-warning system.
The outpatient procedure was successfully performed by cardiac electrophysiologist and cardiologist Andrew J Kaplan of Cardiovascular Associates of Mesa, Mesa, USA.
“The first commercial implant of the Guardian marks a pivotal advancement in cardiac care. The device detects impending ACS events, including silent heart attacks, and leads to earlier patient treatment,” said Kaplan. “Given the device’s clinical success, the cardiovascular community can feel confident in this new, first-in-kind technology. The Guardian fills a true unmet need in high-risk ACS patients.”
The recently approved Guardian device is the first version of the product to be made commercially available. The updated version of the device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device.
“We are elated to bring the Guardian system to market. The device’s ability to provide high-risk heart attack patients with around the clock monitoring offers comfort to both at-risk patients, caregivers, and their healthcare providers said Brad Snow, AngelMed chief executive officer. “We look forward to continuing to have a substantial impact on the standard of cardiology care for years to come.”