Boston gets FDA clearance for new cardiac devices

4 December 2011 (Last Updated December 4th, 2011 18:30)

Boston Scientific has received US Food and Drug Administration (FDA) approval for its Incepta, Energen, and Punctua cardiac resynchronisation therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs).

Boston Scientific has received US Food and Drug Administration (FDA) approval for its Incepta, Energen, and Punctua cardiac resynchronisation therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs).

The devices feature advanced battery longevity and a 4-SITE DF4 connector system. This lowers the volume of the company's single-chamber ICDs to 30.5cc and CRT-Ds to 32cc, maintaining a thickness of less than 10mm.

The DF4 system uses the EZ-4 connector tool, which allows physicians to reduce the time needed for the implant procedure.

Boston Scientific Cardiac Rhythm Management Group chief medical officer Kenneth Stein said the DF4 connector system makes the smallest devices even smaller, increasing patient comfort, and making the implant procedure quicker and easier for physicians.

"The 4-SITE lead is built on the Reliance family of defibrillation leads, which has a demonstrated survival probability of 99% at seven years," Stein said.

The next-generation devices will deliver appropriate therapy, reduce right ventricular pacing, and improve patient management.