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FDA Approves St Jude Medical Unify, Fortify Defibrillators

St Jude Medical, a medical device company, has received FDA approval and first US implants of its Unify cardiac resynchronisation therapy defibrillator (CRT-D) and Fortify implantable cardioverter defibrillator (ICD). The new devices feature advanced battery technology and circuitry that allow for the smallest device footprint in the industry and rapid charge times, without any compromise in device longevity or power.

St Jude Medical said that Unify CRT-D and Fortify ICD have 45J of stored energy and can deliver 40J, the highest energy of any ICD available. The high energy capacity gives the devices the ability to provide safety margin, which could increase the chances that therapy will be successful for patients who may need more energy to correct their heart rhythm.

St Jude Medical said that the devices’ narrow shape, along with their small footprint, allows physicians to implant them using a smaller incision, leading to less time spent closing the incision and a reduced scar for the patient. The company’s SJ4 lead connector system further streamlines the procedure by reducing the number of set screws and connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient’s chest.

Both devices also have features designed to reduce inappropriate or unnecessary defibrillation therapy, while ensuring effective therapy occurs when the patient needs it. The features include advanced sensing technology and more anti-tachycardia pacing options, which can convert many fast ventricular arrhythmias painlessly and avoid the need for high voltage shocks.

An ICD is an advanced implantable device that treats potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD).

St Jude Medical said that the A CRT-D device resynchronises the beating of the heart’s lower chambers (ventricles), which often beat out of sync in heart failure patients, and provides back up treatment for SCD, which is a risk factor associated with certain types of heart failure. The Unify CRT-D and Fortify ICD have previously received European CE Mark approval and were recently fully-launched in Europe.

Eric Fain, president of the cardiac rhythm management division at St Jude Medical, said: “The release of the Unify CRT-D and Fortify ICD families is a strong demonstration of our commitment to providing physicians with technology that puts more control in their hands.

“Our goal with these product lines is to provide physicians with solutions that address their most significant clinical challenges, including patient safety and inappropriate therapy, and to do so while reducing the size of the device.”