News | May 10, 2011

International Launch Begins for Smallest CRT-Ds, ICDs to Treat Heart Failure

May 10, 2011 – The world's smallest and thinnest high-energy cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) to treat heart failure and sudden cardiac death and offer excellent longevity were launched this week in Europe. Boston Scientific Corp. announced the launch and first implants of its Energen and Punctua CRT-Ds and ICDs in Europe and other international markets.

"These devices build on the technological advancements of Cognis and Teligen by providing options to customize therapy for individual patients," said Professor Joachim Winter, M.D., who performed one of the first implants of the Energen ICD with Dong-In Shin, M.D., at the University Hospital Dusseldorf in Germany. "The small profile, coupled with the 4-Site connector system, allowed for an easy implant with a less pronounced physical appearance for the patient."

"Physicians and patients will truly appreciate the longevity of these devices since it may reduce the need for additional implant surgeries," said Peter Lecher, M.D., who performed one of the first implants of the Energen CRT-D with Gunther Prenner, M.D., at the Medical University in Graz, Austria. "Additionally, the new therapy options, combined with the Latitude patient management system, increase the variety of diagnostic parameters to help treat heart failure patients."

Most of the new Energen and Punctua devices offer the 4-Site DF4 connector system option, designed to simplify the implant procedure and comply with international connector standards. Additionally, nearly all models are compatible with Boston Scientific's Latitude patient management system, which enables physicians to remotely monitor implantable cardiac device patients between on-site office visits.

The company received CE mark approval for its Energen and Punctua CRT-Ds and ICDs in October 2010. In the United States, they are investigational devices, limited by applicable law to investigational use and not available for sale. The company expects U.S Food and Drug Administration (FDA) approval for the devices in late 2011 or early 2012.

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