St Jude Medical has announced Australian Therapeutic Goods Administration approval of the Current Accel implantable cardioverter defibrillator (ICD), AnalyST Accel ICD, Promote Accel cardiac resynchronisation therapy defibrillator (CRT-D), Durata high-voltage cardiac lead, and its SJM Confirm implantable cardiac monitor.
The Accel devices provide new automatic therapy adjustments and unprecedented insight into patient conditions that allow physicians to more efficiently deliver therapy and manage patients’ conditions at the time of implant through follow-up. Features including total pacing capture confirmation and alerts for atrial fibrillation and atrial tachycardia allow physicians to tailor therapy to changing patient needs.
In addition to the family wide features of the Accel devices, the AnalyST Accel ICD introduces first-to-market ST segment monitoring diagnostic algorithm, which can add important and never-before-available information to assist in medical decision making and accelerate patient care. The AnalyST Accel ICD continuously monitors for specific changes in the ST segment of the electrocardiogram that can indicate the onset of serious conditions such as ischaemia. Because many cardiac episodes are transient in nature, the continuous ST monitoring capability available in the AnalyST Accel ICD gives physicians more comprehensive information over time compared to the standard electrocardiogram that would otherwise only be recorded in the physician’s office.
The Current Accel and AnalyST Accel ICDs are advanced implantable devices that treat potentially lethal, abnormally fast heart rhythms, which often lead to sudden cardiac death.
The Promote Accel CRT-D device resynchronises the beating of the ventricles and provides back up treatment for sudden cardiac death.
In ICD therapy, lead durability is a critical characteristic for withstanding the conditions inside the body and issues during lead implantation. The Durata defibrillation lead is designed to meet these challenging demands. The lead is intended to enhance ease of use and handling for implanting physicians by featuring a soft silicone tip with a larger surface area than previous generation leads, and a slightly-curved right ventricle shock coil. The Durata 7F lead is also the smallest diameter lead on the market. Small diameter leads may be especially helpful for patients with compromised blood flow or a narrow vasculature, or patients who need CRT-D.
The Durata lead incorporates Optim insulation, a hybrid insulation material unique to St Jude Medical that was created specifically for cardiac leads. Optim insulation blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane to provide increased durability and flexibility.
The Confirm ICM device monitors for and simplifies the diagnosis of fainting or dizziness. The device is about the size of a computer thumb drive, and is the smallest implantable cardiac monitor on the market. It is implanted subcutaneously in the upper chest region and can be implanted in an outpatient procedure under local anaesthesia.
The SJM Confirm ICM streamlines the diagnosis of syncope by continuously monitoring the cardiac rhythm and recording patient-initiated as well as automatically-triggered events. This ability to review the patient’s heart rhythm at the precise time the patient experiences symptoms allows the physician to better identify the abnormal rhythms causing the symptoms.