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Continued: St. Jude starts U.S. test for its tiny pacemaker

  • Article by: JAMES WALSH , Star Tribune
  • Last update: February 6, 2014 - 8:51 PM

Nanostim is his first pacemaker.

Dobin, whose heart rate was dropping as low as 28 beats per minute, said doctors told him the device would be less invasive than a conventional pacemaker, yet perform just as well.

“I was close to death. I want to live,” said the man who emigrated to the United States from Ukraine 37 years ago. “Now you can check your watch to my heartbeat.”

Said his daughter: “It took them a lot longer to prep him before the surgery than it did to do the procedure itself.”

The Leadless II pivotal trial will evaluate the safety and effectiveness of the Nanostim and will enroll approximately 670 patients at 50 centers in the United States, Canada and Europe. In preliminary trials, the device performed about the same as conventional pacemakers, St. Jude said. Implanting the pacemaker took an average of 28 minutes.

Even with a smaller battery, the device is expected to have a battery life span of more than nine years at 100 percent pacing and more than 13 years at 50 percent pacing.

Nanostim was approved for sale in Europe and other markets in 2013. It is not yet available for sale in the U.S.

 

James Walsh • 612-673-7428

  • related content

  • A depiction of St. Jude Medical's Nanostim pacemaker inside a human heart.

  • St. Jude’s Nanostim pacemaker is about the size of a AAA battery and does not use wires to connect to the heart.

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