European approval for Boston Scientific defibrillator
9 January 2008
Boston Scientific Corporation (NYSE:BSX) has gained the CE
Mark approval for its Livian cardiac resynchronization therapy defibrillator
(CRT-D), which treats heart failure and helps protect patients at risk of
sudden cardiac death. The CE Mark allows the company to market the device in
The Livian CRT-D is specifically designed to monitor heartbeats in heart
failure patients and deliver small electrical impulses that may improve the
heart's pumping ability.
The implantable device uses Boston Scientific proprietary technology and
is designed to improve a patient's response to cardiac resynchronization
therapy. It also offers clinicians technology to help manage heart failure
patients with frequent atrial arrhythmias.
"This next-generation CRT-D
offers physicians in Europe and elsewhere even more flexibility for
tailoring therapy to each patient," said Jim Tobin, President and Chief
Executive Officer of Boston Scientific. "It is a testament to our ongoing
commitment to providing innovative solutions for the treatment of heart
Heart failure is a debilitating condition in which the heart
weakens and gradually loses the ability to pump blood effectively. Nearly 22
million people worldwide — including approximately 6.5 million in Europe —
currently suffer from heart failure, which affects not only a patient's
quality of life, but also life expectancy. Nearly one million new cases of
heart failure are diagnosed annually, making it the most rapidly growing
This is the first approval of a Boston
Scientific-branded cardiac rhythm management device to treat heart failure.
The LIVIAN CRT-D is pending approval by the US Food and Drug Administration
and is not available for sale in the United States.