St. Jude Medical, Inc. (NYSE:STJ) today announced it has launched several new cardiac rhythm management devices for the treatment and diagnosis of abnormal heart rhythms. The company announced Australian Therapeutic Goods Administration (TGA) approval of the Current™ Accel implantable cardioverter defibrillator (ICD), the AnalyST™ Accel ICD and the Promote™ Accel cardiac resynchronization therapy defibrillator (CRT-D); the Durata™ high-voltage cardiac lead; and its SJM Confirm™ implantable cardiac monitor.

"These devices demonstrate St. Jude Medical's commitment to providing physicians access to timely, actionable information about their patients' heart rhythms, and unique tools that allow them to treat individual patient needs," said Eric S. Fain, M.D., president of the Cardiac Rhythm Management Division at St. Jude Medical. "The approval of these new products gives physicians the ability to improve cardiac disease management."

About the Accel Family of Devices

The St. Jude Medical 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 ischemia (which occurs when blood flow/oxygen to the heart muscle is obstructed). Changes in the ST segment also have been linked to significant clinical events such as heart attacks. 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 (ECG or EKG) 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 (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD).

The Promote Accel CRT-D device resynchronizes 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. Studies have shown that CRT (cardiac resynchronization therapy) can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood.

About the Durata High Voltage Lead

In ICD therapy, lead durability is a critical characteristic for withstanding the conditions inside the body and issues during lead implantation. The St. Jude Medical 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 (RV) 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.

A defibrillation lead is an insulated wire that serves as a conduit between an ICD and the heart. The lead sends electrical signals from the device to the heart to provide therapy needed to address abnormal heart rhythms. The lead also carries information from the heart back to the implanted device, where the data can be used by the device to deliver therapy or make automatic adjustments, and used by physicians to determine optimal device settings and therapies for each patient.

About the SJM Confirm ICM

The SJM 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 just under the skin (subcutaneously) in the upper chest region and can be implanted in an outpatient procedure under local anesthesia.

The SJM Confirm ICM streamlines the diagnosis of syncope (fainting) 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.

According to some physicians, unexplained syncope (fainting) is one of the hardest diagnoses to make. In fact, even after a physical examination and ECG evaluation through a Holter monitor, approximately half of all cases of unexplained syncope go undiagnosed. The SJM Confirm ICM overcomes many of the challenges of traditional diagnostic tools by offering continuous long-term cardiac monitoring for effectively detecting infrequent syncope events.

Source
St. Jude Medical