St. Jude Medical’s Unify cardiac resynchronization therapy defibrillator (CRT-D) and Fortify ST implantable cardioverter defibrillator (ICD), which were FDA approved and CE Marked last year, have now been cleared for distribution in Japan. The Unify and Fortify are the smallest CRT-D and ICD on the market, which allows surgeons to use smaller incisions during implantation. The devices can also deliver more energy than existing options, and use SJM’s proprietary algorithms to monitor patients and reduce the likelihood of unnecessary shocks.
From the announcement:
The Unify CRT-D and Fortify ST ICD feature advanced battery technology and circuitry that allow for a smaller device, with more energy capacity and rapid charge times, all while increasing device longevity. The energy capability of a device is particularly important for patients who have an enlarged heart, low ejection-fraction, advanced heart failure or previously demonstrated a high defibrillation threshold (the amount of energy required to shock the heart back to a normal rhythm). These devices feature 40J of delivered energy (45J stored) – the highest energy level available in the industry – helping to ensure that therapy will be successful for those patients who require a higher energy shock for defibrillation.
Press release: St. Jude Medical Announces Japanese Launch of Smaller, Higher Power ICD and CRT-D Devices…
Flashbacks: SJM’s Unify CRT-D and Fortify ICD Defibrillators Now FDA OK’ed; St. Jude Medical Gets Go Ahead for New Implantable Cardiac Devices