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First leadless pacemaker receives CE mark
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St. Jude Medical has announced that the Nanostim leadless pacemaker received CE mark approval in Europe.
This is the first leadless pacemaker to reach the market, according to the company.
The pacemaker is implanted directly into the heart via a minimally invasive procedure, using a steerable catheter through the femoral vein, and eliminating the need for a subcutaneous pocket or leads. The device is less than 10% the size of a conventional pacemaker and was designed to be fully retrievable, according to the press release.
Initial results from the LEADLESS study presented at the Heart Rhythm Society Annual Scientific Sessions earlier this year demonstrated overall device performance comparable to conventional pacemakers.
The device also recently received FDA conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating the Nanostim leadless pacemaker in the United States, according to the release.
In addition, St. Jude Medical announced completion of its acquisition of Nanostim, Inc. The acquisition adds the leadless pacemaker to the St. Jude Medical product portfolio and culminates a 2-year partnership between the two companies.