Boston Scientific Corporation (NYSE: BSX) announced FDA approval of its INCEPTA, ENERGEN and PUNCTUA cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) to treat heart failure and sudden cardiac death. The company says the new devices offer enhanced therapy options, advanced battery longevity -- while incorporating the proprietary DF4 universal connector system in what is billed as the medical implant industry's smallest and thinnest platform.
The company says its 4-SITE DF4 connector system reduces the volume of its single-chamber ICDs to 30.5cc and CRT-Ds to 32cc, while maintaining a thickness of less than 10mm. The system is also designed to simplify and reduce the time needed for the implant procedure by combining three separate lead terminals into one integrated connection and leveraging the new EZ-4 Connector Tool which allows physicians to reduce the number of steps required during implant.
"The DF4 connector system makes the industry's smallest devices even smaller, potentially increasing patient comfort and making the implant procedure quicker and easier for physicians, while the new features will offer even more options for customizing patient care," said Kenneth Stein, M.D., Chief Medical Officer of Boston Scientific's Cardiac Rhythm Management Group. "The 4-SITE lead is built on the RELIANCE family of defibrillation leads, which has a demonstrated survival probability of 99 percent at seven years."
The first implant of the company's next-generation INCEPTA ICD occurred this week at the University of Washington Medical Center in Seattle by Jeanne E. Poole, M.D., FHRS, FACC, Professor of Medicine and Director, Arrhythmia Service and Electrophysiology Laboratory.
"These devices are a direct response to what patients tell us they want the most -- small, thin, long-lasting devices that provide appropriate therapy when necessary," said Dr. Poole. "Additionally, these devices are designed to streamline the implant procedure with Boston Scientific's 4-SITE DF4 connector system."
The new cardiac implant devices also include options to promote appropriate therapy, reduce right ventricular pacing, and improve patient management through the availability of the LATITUDE Heart Failure Management weight scale and blood pressure cuff sensors. "Including remote monitoring as a standard for patients will assist physicians involved in the management of this very complex disease. By involving patients in that process, it could also motivate them to become more engaged in their own care," noted Leslie A. Saxon, M.D., Chief of Cardiovascular Medicine at University of Southern California, and Committee Chair of the ALTITUDE Clinical Program sponsored by Boston Scientific. "In the ALTITUDE Survival study, patients with remote monitoring had a lower mortality rate."
"Boston Scientific is providing physicians a choice of premium high-energy devices that are the world's smallest and thinnest, offer advanced battery technology with excellent longevity, and are backed by the longest warranty in the industry of up to 10 years," concludes Joe Fitzgerald, Senior Vice President and President of Boston Scientific's Cardiac Rhythm Management Group. "This new portfolio of products, built on our tradition of innovation, will provide physicians with flexible therapeutic options designed to match specific patient needs."
For more information, visit: www.bostonscientific.com.
