Boston Scientific Announces European Approval of Next-Generation Implantable Defibrillator
NATICK, Mass., Oct. 9 -- Boston Scientific Corporation today announced CE Mark approval of its CONFIENT(TM) implantable cardioverter defibrillator (ICD). This approval represents the first Boston Scientific-branded cardiac rhythm management device to treat sudden cardiac death (SCD).
The CONFIENT ICD, with an enhanced AV Search Hysteresis feature, is designed to reduce unnecessary right ventricular pacing. This product also contains wireless capability that is designed to save physicians time during implant by allowing device programming during wound closure while also eliminating the need for the wand in the sterile field. It also saves time at follow-up with device interrogations that can be three times faster than the Company's wanded telemetry.
"The CONFIENT ICD is a tangible example of our Cardiac Rhythm Management group's ability to deliver meaningful product innovation," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We look forward to making this ICD broadly available to physicians so they can offer this advanced therapy to patients who are at risk of sudden cardiac death."
Sudden cardiac death is the abrupt loss of heart function, usually due to an electrical rhythm dysfunction in the lower chambers of the heart, called ventricular fibrillation. Each year, sudden cardiac death claims the lives of as many as 350,000 people in Europe alone. More people die from sudden cardiac death each year than from lung cancer, breast cancer and AIDS combined.
An ICD is a small implantable device about the size of a box of matches. It's placed under the skin just below the collarbone. The device uses leads (wires threaded into the heart's chambers) to monitor every single heartbeat. If a potentially deadly rhythm is detected, a lifesaving shock is delivered, restoring normal heart rhythm and preventing sudden cardiac death.
The CONFIENT ICD is not available for sale in the United States.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
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