FDA approves new, smaller heart device made by St. Jude Medical

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Covidien FDA approvalThe U.S. Food and Drug Administration has approved a new, smaller implantable cardioverter defibrillator made by St. Jude Medical (NYSE:STJ), the medical device maker announced Wednesday.

The announcement comes less than a month after the device maker said that European regulators had given the nod to the same device — the Ellipse ICD.

The Ellipse is the industry’s smallest high-voltage ICD, said a company news release that described the product as the result of physician input. The device design was arrived at through focus groups of physicians who translated their vision in clay.

“We feel collaboration with physicians in regards to the planning and design of our devices is imperative in order to develop truly breakthrough technologies,” said Dr. Eric S. Fain, president of the St. Jude Medical Cardiac Rhythm Management Division, in a statement.

On Tuesday, St. Jude Medical announced that it had won  FDA approval on its Assura line of ICDs and CRT-Ds.

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Arundhati Parmar

By Arundhati Parmar

Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.
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