Biotronik Pacemakers Receive CE Mark

Biotronik has received CE Mark approval for two of its next generation pacemakers that are safe to use with 3T MRI scanners, the company announced this week.

Biotronik claims it is the only company to offer implantable cadioverter-defibrillators and pacemakers approved for 3T scans. It says the 3T models offer superior image quality and a shorter scan time than previous models.

The company has a website where physicians to verify if a patient’s device and lead combination are MRI conditional and under which scanning conditions. The website offers information in five languages, English, French, German, Italian and Spanish.

Headquartered in Berlin, Germany, Biotronik is one of the leading manufacturers of cardiovascular and endovascular devices. Several million patients have received the company’s implants or have been treated with coronary and peripheral vascular intervention products since it developed its first pacemaker in 1963. — John Bechtel