St Jude Medical gains EU approval for high power ICD and CRT-D devices

9 February 2010

St Jude Medical, Inc. (NYSE:STJ) has announced European CE Mark approval and first implants of its Fortify and Fortify ST implantable cardioverter defibrillators (ICD) and Unify cardiac resynchronization therapy defibrillator (CRT-D).

The devices will be fully launched in Europe later this spring, and US versions of the Fortify ICD and Unify CRT-D are expected to be launched later this year. The reduced size of these new devices compared to those of previous generations creates the smallest available device footprint in the industry.

The Fortify ICD and Unify CRT-D 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) helping to ensure that therapy will be successful for those patients who require a higher energy shock for defibrillation.

Because of the devices’ narrower shape, physicians can implant them using a shorter incision, leading to less time spent closing the incision and a smaller scar for the patient. The company’s SJ4 lead connector system further streamlines the procedure by reducing the number of connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient’s chest.

The Unify CRT-D and Fortify ICD also incorporate the new CorVue pulmonary congestion monitoring algorithm. This new feature alerts physicians when a patient’s heart failure may be worsening, as evidenced by changes in electrical signals that can be correlated to increased congestion, or fluid retention, in the chest area. The algorithm continuously monitors fluid retention in multiple vectors, providing an accurate diagnostic and an alert designed to minimize false positives.

“These new devices have been designed to address many of the clinical issues facing our customers, from enhanced patient safety, reduction of inappropriate therapy and streamlined implant procedures, to improved disease management of cardiac conditions,” said Eric S Fain, MD, president of the St Jude Medical Cardiac Rhythm Management Division. “Our goal with this product line is to address all these needs and do so while reducing the size of the device without compromising on either delivered energy or device longevity.”

Both devices also have features that are designed to assist in the reduction of unnecessary shocks, including painless anti-tachycardia pacing, which can be used for fast ventricular arrhythmias prior to or while the device is preparing to deliver shock therapy, and other enhanced technology for reducing inappropriate therapy.

“This new device platform provides a number of new features that will help me to improve management of my patients with ICD and CRT-D devices, while delivering new safety features on top of St Jude Medical’s already reliable technology,” said Prof. Werner Jung of Schwarzwald-Baar Klinkum in Villingen-Schweningen, Germany. “The combination of the devices’ smaller size and SJ4 connector system also streamlines the implant procedure and makes the device more comfortable for my patients.”

In addition to the family-wide features of the Unify and Fortify devices, the Fortify ST ICD features St Jude Medical’s first-to-market ST segment monitoring diagnostic algorithm, which can add important information to assist in medical decision making and accelerate patient care.

The Fortify ST 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). Because many cardiac episodes are transient in nature, the continuous ST monitoring capability available in the Fortify ST 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.

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). Approximately 325,000 people per year in the U.S. die suddenly of SCD.

A 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 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed every year, according to the American Heart Association.

The Unify CRT-D and Fortify ICD are pending approval by the US Food and Drug Administration (FDA).