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Boston Scientific announces CE Mark approval for Livian
Boston Scientific has announced that its cardiac resynchronisation therapy defibrillator (CRT-D) Livian has received CE Mark approval.
Livian is indicated for use in the treatment of heart failure and helps protect patients from the risk of sudden cardiac death.
This European approval is the first approval of a Boston Scientific-branded cardiac rhythm management device to treat heart failure.
Livian CRT-D is now waiting on approval from the US Food and Drug Admission and if successful will be available in the United States.
The defibrillator has been designed to monitor heartbeats in heart failure patients and delivers small electrical pulses that aim to improve the heart’s pumping ability.
It also enables health professionals to customise therapy based on the patient’s individual needs, Boston Scientific reports.
Jim Tobin, president and chief executive officer of Boston Scientific, confirmed that Livian would offer physicians more “flexibility” for tailoring therapy to each patient.
“It is a testament to our ongoing commitment to providing innovative solutions for the treatment of heart failure,” he added.
Last month, Boston Scientific announced that its Taxus Liberte paclitaxel-eluting coronary stent had received European CE Mark approval for its use in patients with diabetes.
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