Tiny Leadless Pacemaker Earns CE Mark Approval

Disclosures

October 14, 2013

ST PAUL, MN — St Jude Medical today announced that the leadless pacemaker (Nanostim), an intracardiac device that has done away with arguably their most problematic component, has been given CE Mark approval for sale in Europe[1]. It is the first such device to reach the market, the company said.

The medical device giant also announced that it has completed acquisition of the device's developer, culminating "a two-year partnership between the two companies during which St Jude Medical invested in and collaborated with Nanostim throughout its product development and commercialization initiatives."

The leadless pacemaker is a tiny cylinder "that resembles an AAA battery" and is inserted within the right ventricle via the femoral vein using a steerable catheter, according to St Jude, so there is no need for a subcutaneous pocket or leads of any kind. Its average battery lifespan is estimated to be 8.5 years with 100% pacing. The device is designed to be entirely retrievable.

A pivotal trial to evaluate the device in support of an application to the US Food and Drug Administration is in planning stages.

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