Tiny Leadless Pacemaker & Huge Packaging Challenges

The Nanostim Leadless Pacemaker recently received CE Mark approval and will be available soon in select European markets. It also recently received US Food and Drug Administration (FDA) conditional approval for its investigational device exemption (IDE) application, and clinical trial protocol will begin evaluating the technology in the US.

Vimal K. Puthiyadath

This disruptive innovation has definitely found solutions to many device packaging challenges. This is a pinnacle of success as far as biocompatibility is concerned, since the device is implanted inside the heart.

  • The material selection is extremely important, as this device is meant to be inside the heart for a minimum of eight years (battery life eight to nine years).
  • The coating on the device must ensure permanent barrier against bacteria.
  • The device has a pulse generator that includes a battery and a steroid-eluting electrode that sends pulses to the heart when it recognizes a problem with the heart’s rhythm. The drug-eluting electrode is another component which is electrically conducting but also acts as a reservoir for the drug.
  • The device offers a less-invasive approach that eliminates the surgical pocket and lead, potentially reducing overall complications such as device-related infection of the pocket and lead failure.
  • The small size of the device, coupled with the lack of a surgical pocket, improves patient comfort.
Image provided courtesy of St. Jude Medical, Inc.

In addition, the removal of patient activity restrictions that may prevent the dislodgement of a conventional lead may potentially improve the quality of life for patients with this technology.

The packaging challenges of this device are evident: it is tiny, it contains a drug, and it uses a battery that has to last at least eight years. How would you package this device?

Focused on medical packaging design and technology?

Vimal K. Puthiyadath, Biomedical Electronics Engineer

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