European approval for Boston Scientific defibrillator9 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 Europe. 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 failure." 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 cardiovascular disorder. 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. |
