Fully Implantable Heart Pump Wins FDA Breakthrough Designation
Posted November 6, 2019
The Food and Drug Administration (FDA) has awarded breakthrough status for an implantable and fully internal left ventricular assist device (LVAD), or heart pump.
Developed by Medtronic, the new LVAD design is intended to increase oxygenated blood flow through the body for patients with advanced heart failure without the need for wires leading to an external power source.
The FDA’s voluntary Breakthrough Devices Program, finalized in February, is intended to create a more agile process for clearing devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions, according to the agency, while potentially accepting greater benefit-risk uncertainty.
By receiving a breakthrough designation, Medtronic’s LVAD will receive “priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions,” said the company in a press release.
Implantable LVADs help the heart to pump oxygenated blood from the left ventricle to the rest of the body. LVADs currently on the market require an external cord that attaches to a power source, which may be a battery pack or power adapter. The proposed design by Medtronic, which the company says is still in the early stages of development and is not available on the market, would eliminate that connection.