St. Jude Medical, announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and the launch of the Fortify ST implantable cardioverter defibrillator (ICD) and Unify cardiac resynchronisation therapy defibrillator (CRT-D). The reduced footprint of these new devices makes them the smallest available in the industry.
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. 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.
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 DF4 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 size and shape of the Unify and Fortify ST devices are significantly smaller than that of the current devices, which is truly helpful as patients in Japan tend to be smaller than those in Western countries,” said Hideo Okamura from the National Cerebral and Cardiovascular Centre in Osaka, Japan. “Although smaller, these devices have an extended longevity and a stronger output of energy for shock therapy. Taken together, I believe that these enhanced features will improve patient care.”
“The Unify and Fortify ST devices were designed to address many of the clinical issues facing our customers, and at the same time reduce the size to make them more comfortable for patients,” said Eric S Fain, president of the St. Jude Medical Cardiac Rhythm Management Division. “We are happy to offer devices in Japan with the industry’s smallest footprint that will improve disease management of cardiac conditions.”
The Unify CRT-D and Fortify ST ICD also incorporate the new CorVue monitoring algorithm. This new feature alerts physicians to variations in thoracic impedance, a measurement that helps physicians better understand a patient’s heart failure status. The algorithm continuously monitors thoracic impedance as a surrogate for fluid retention in multiple vectors, providing information that may be used to index the level of heart failure.
The devices also feature the company’s ShockGuard technology, which is designed to reduce inappropriate and unnecessary shocks for patients. The programming in ShockGuard discriminates between rhythms that require defibrillation therapy and those that do not. Additionally, the advanced sensing technology designed to avoid sensing unwanted signals (T-waves) and offer more anti-tachycardia pacing options, which can convert many fast ventricular arrhythmias painlessly and avoid the need for high voltage shocks. A retrospective analysis of the Advancements in ICD therapy (ACT) registry, which enrolled more than 5,000 patients and allowed programming at the physician’s discretion, demonstrated that at the end of one year, 98.5% of patients with the ShockGuard programming would be free of inappropriate shocks.
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 ischaemia.
Takashi Noda from the National Cerebral and Cardiovascular Centre added, “It is very important for us as physicians to utilise as many indications and diagnostic data as we can for each heart failure patient therapy and follow up. In addition to the additional data provided with the CorVue, the new devices also have new features and settings that help to reduce inappropriate and unnecessary shock therapy.”
With the device’s monitoring diagnostic, small changes in ST segment are continuously and precisely recorded and plotted, and then retrieved for the physician to review during patient follow-up visits. Because many cardiac episodes are transient in nature, continuous ST Monitoring is important as it gives physicians more comprehensive ST segment information over time rather than sporadic diagnostic reports when the patient is in the clinic or hospital.