Boston Scientific Corporation (NYSE: BSX) today announced the launch and first implants of its ENERGEN™ and PUNCTUA™ cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) in Europe and other international markets. They are the world’s smallest and thinnest high-energy devices to treat heart failure and sudden cardiac death and offer excellent longevity.
“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 ENERGEN and PUNCTUA devices are designed to improve the ability of physicians to deliver effective patient care,” said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. “This new portfolio of products, built on our tradition of innovation, continues our advantages in size, shape and longevity and provides multiple therapy options to match specific patient needs.”
The Company received CE Mark approval for its ENERGEN and PUNCTUA CRT-Ds and ICDs in October 2010. In the U.S., they are investigational devices, limited by applicable law to investigational use and not available for sale. The Company expects Food and Drug Administration approval for the devices in late 2011 or early 2012.