Medtronic announced it has received a breakthrough device designation from the FDA for its fully implantable left ventricular assist device for patients with advanced HF.
The LVAD system (Medtronic Fully Implantable Left Ventricular Assist Device) includes an implanted heart pump that increases the amount of blood circulating through the body, according to a press release issued by the company.
The system is designed to be fully implanted inside the body, according to the release. In contrast, current pumps are connected to a driveline cable that extends outside the body to a controller, which is connected to a power source such as an AC or DC adapter or batteries, the company stated in the release.
As part of the designation, the agency will give the device priority review and communicate with the company on device development, clinical trial protocols and other matters, according to the release.
The device is in the early stages of development and is not yet available for commercial use. – by Scott Buzby