FDA grants breakthrough status to Medtronic heart device

30 October 2019 (Last Updated October 30th, 2019 12:11)

Medical device maker Medtronic has secured Breakthrough Device designation from the US Food and Drug Administration (FDA) for its completely implantable Left Ventricular Assist Device (LVAD) for patients suffering with advanced heart failure.

FDA grants breakthrough status to Medtronic heart device
Medtronic’s stent is intended to provide an off-the-shelf endovascular solution for treating thoracoabdominal aortic aneurysm. Credit: Medtronic plc.

Medical device producer Medtronic has secured Breakthrough Device designation from the US Food and Drug Administration (FDA) for its implantable Left Ventricular Assist Device (LVAD) for patients suffering from advanced heart failure.

LVAD systems include an implanted heart pump to raise the amount of blood circulating the body.

The pump is linked to a driveline cable, extending outside the body to a controller, then connected to power sources (AC or DC adapter, batteries).

The future system is designed to be fully implanted within the body.

The FDA Breakthrough Device Programme is designed to help patients receive access to breakthrough technologies that come with the potential to offer more effective treatment or diagnosis for life-threatening or debilitating diseases.

Under the programme, the FDA will offer Medtronic with priority review and interactive communication concerning device development and clinical trial protocols, through to commercialisation decisions.

The Medtronic Fully Implantable LVAD is currently in early stage research and development and is not available for sale anywhere in the world.

Medtronic provides a range of medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

Earlier this month, the US FDA granted breakthrough device designation to Medtronic’s minimally invasive Valiant TAAA Stent Graft System.

Valiant TAAA Stent Graft System is designed to repair a thoracoabdominal aortic aneurysm (TAAA). A TAAA causes swelling of the aorta, extending from the chest into the abdomen.

Commonly, TAAA impacts the branch arteries supplying blood to several internal organs. The condition accounts for approximately 15% of all thoracic aneurysms.