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April 17, 2014

Boston Scientific obtains FDA approval for new defibrillators, heart failure devices

Boston Scientific has obtained US Food and Drug Administration (FDA) approval for its latest generation of defibrillators and heart failure devices designed to advance patient care.

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Boston Scientific has obtained US Food and Drug Administration (FDA) approval for its latest generation of defibrillators and heart failure devices designed to advance patient care.

The four newly approved devices include the Dynagen Mini and Inogen Mini ICDs, as well as the Dynagen X4 and Inogen X4 CRT-Ds.

Extending the Boston Scientific portfolio of defibrillators, the ICDs in the MINI family are the world’s smallest and thinnest devices, designed for patient comfort.

The Dynagen Mini and Inogen Mini ICDs are up to 20% smaller by volume and up to 24% thinner than competitive devices from other manufacturers.

University Marien Hospital Herne, Hospital of Ruhr-University, Bochum, Germany Dr Hans-Joachim Trappe said the tiny size of the Mini ICD provides a real benefit to some patients, in particular those with a smaller frame.

"The Mini ICD not only improves patient comfort, but also provides these patients with innovative technology to help treat life-threatening arrhythmias of the heart," Dr Trappe said.

"Our devices offer more options to improve outcomes, reduce complications and lower the costs of treating patients."

The X4 line of quadripolar CRT-Ds offers 70% more pacing options to effectively address high capture thresholds and phrenic nerve stimulation. These quadripolar CRT-Ds are equipped with the largest battery capacity in the industry.

ICDs and CRT-Ds are used to protect against sudden cardiac death due to abnormal heart rhythms in patients suffering from heart failure, when the heart is unable to pump blood sufficiently.

According to the company, these newly approved devices have a projected longevity and six-year CRT-D warranty.

Boston Scientific Rhythm Management division executive vice-president and president Joe Fitzgerald said with these new devices and company’s current line of long-lasting ICDs and CRT-Ds offer a range of options for patients at risk of sudden cardiac arrest with or without the need for cardiac resynchronisation therapy.

"Our devices simply offer more options to improve outcomes, reduce complications and lower the costs of treating patients," Fitzgerald said.


Image: Boston Scientific’s Corporate Headquarters in Natick, Massachusetts, US. Photo: courtesy of Boston Scientific Corporation.

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