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Home Industry News Biotronik receives European approval for new pacemaker

Biotronik receives European approval for new pacemaker

9th April 2010

Biotronik has been granted approval by European regulators for a new cardiac pacing system which is compatible with magnetic resonance imaging (MRI) scans.

The medical device company’s ProMRI Pacing Systems consist of an Evia series pacemaker and Safio S pacing leads and have been designed to allow patients to undergo MRI diagnosis in certain conditions.

This approval is based on the results of several trials, which tested the effectiveness of the system in various combinations of device and lead positions, body positions and scanning time periods.

According to Biotronik, this represents the first time a whole pacemaker series has been ratified for use in conjunction with MRI.

Marlou Janssen, vice-president of global marketing and sales for cardiac rhythm management at Biotronik, said: “We are very pleased to offer physicians the choice to select from a series of the most technologically advanced pacemakers and at the same time give their patients access to MRI diagnostic procedures.”

Last month, the company announced the first implantation of its Lumax DX System, a single chamber implantable cardiac device for use in monitoring atrial fibrillation and other heart conditions.

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