FDA NewsPerspective

Fully implantable LVAD nets FDA breakthrough device designation

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

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

    Perspective
    Frank Smart

    Frank Smart

    This is very important. Currently, LVADs need an external battery and controller, as stated in the press release. Many of the major problems with LVADs relate to the driveline through the skin. This is where most infections start, and it leads to systemic infections. Additionally, when the patient with an LVAD gets infected, their clotting is made worse and there is a higher stroke risk. This has been well-established in all LVADs.

    Everyone who has an LVAD would benefit from not having a driveline and a fully implantable device. Currently, people can’t shower or bathe without special care and equipment. Simple things like getting dressed or undressed require much more time and effort.

    Obviously, this assumes the device works and is able to support the patient “untethered” for at least 20 to 45 minutes. This has been a goal of LVAD manufacturers for more than 20 years. I am not familiar with the new technology, but it sounds very exciting.

    • Frank Smart, MD
    • Cardiology Today Editorial Board Member
      LSU School of Medicine

    Disclosures: Smart reports no relevant financial disclosures.