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Boston Scientific Offers New CRT-D Warranty Program Covering Phrenic Nerve Stimulation
Date:5/5/2011

NATICK, Mass., May 5, 2011 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it is offering a new warranty program in the U.S. that covers its cardiac resynchronization therapy defibrillator (CRT-D) devices and leads in the event of chronic phrenic nerve stimulation (PNS).

"Under the program, implanting centers in the U.S. can qualify for a full refund if they have to replace a Boston Scientific COGNIS® CRT-D device, attached to any Boston Scientific bipolar left ventricular (LV) lead, with a competitive device due to unmanageable PNS within six months post-implant," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific.  "With this warranty program, we are firmly standing behind the performance of our CRT-D devices and LV lead portfolio to ensure patients get the heart failure therapy they need without complications related to phrenic nerve stimulation."

PNS is an occasional complication of CRT therapy due to close proximity of the phrenic nerve to the desired pacing location in the left ventricle.  It causes the diaphragm to contract, resulting in a "hiccup-like" sensation and patient discomfort.  To avoid PNS when it occurs, physicians attempt to reprogram the device to use a different pacing configuration.  If this fails to correct the issue, physicians must manually reposition the lead (insulated wire used to stimulate the heart) into a new location.  If PNS manifests after the implant procedure has been completed, lead repositioning would require a second surgery.  

"This warranty is based on confidence in our CRT-D system's performance and physicians' ability to avoid PNS when using it," said Kenneth Stein, M.D., Chief Medical Officer, Cardiac Rhythm Management for Boston Scientific.  "Physicians must also consid
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