St. Jude Medical (St. Paul, Minnesota) reported FDA approval of the Promote Plus cardiac resynchronization therapy defibrillator (CRT-D) and Current Plus implantable cardioverter defibrillators (ICDs), designed with TailoredTherapy features that give physicians more options for customizing therapy for patients with potentially lethal heart arrhythmias and heart failure.

"There is no 'textbook' patient. Each person presents a unique anatomy, disease state and response to therapy," said Eric Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division. "With the feature set available in the Promote Plus and Current Plus devices, physicians can customize programming to ensure each patient is receiving therapy that is appropriate for his or her individual condition."

In an e-mail response to Medical Device Daily's questions, St. Jude said its ICDs and CRT-Ds (Current RF & Current Plus / Promote RF & Promote Plus) are designed with patient safety as the first priority. "Three distinct operating modes provide redundant levels of operation to ensure life saving therapy is available even in the unlikely event of a component failure," Amy Jo Meyer, a company spokesperson told MDD. She added that longevity projections for Current Plus and Promote Plus may exceed competitive longevity projections. The Plus family has "unmatched" intra-cardiac electrogram storage capacity with 45 minutes of data available to give clinicians the most clinical data available to make more informed decisions about their patients' arrhythmia status.

According to St. Jude, the Promote Plus CRT-D and Current Plus ICDs also offer a smoother header configuration designed to offer better patient comfort and improve visibility at the connector site, where the thin wire (the lead) that delivers the electricity from the device to the heart is connected.

Meyer further explained to MDD that the header (the top of the device where the leads are connected) on the Plus devices has been made with additional epoxy to fill in spaces around the set screws, making it smoother. The smoother header will be more comfortable for the patient, she said.

To better assist physicians in accurately diagnosing and managing patients with fast rates in the heart's upper chambers (atria), the Promote Plus CRT-D and Current Plus ICDs also include a new atrial tachycardia/atrial fibrillation (AT/AF) Alert feature, the company noted. This feature is designed to notify physicians when a rapid atrial rate exceeds a programmed value and occurs over an extended time period.

These devices also can be programmed to notify the patient through a vibratory alert, St. Jude said. Additionally, the devices have the ability to inform the patient's clinic through the St. Jude Medical Merlin@home transmitter and Patient Care Network. These features allow the physician to better manage patients' atrial arrhythmias, such as AF, St. Jude said.

The Promote Plus CRT-D and Current Plus ICDs are built on the St. Jude Medical consolidated hardware and software Unity device platform and include the company's advanced safety features and algorithms for better patient management. These include improved lead monitoring capabilities – including daily checks of all pacing and shock configurations – that provide added patient safety.

According to St. Jude, TailoredTherapy features in these devices include:

QuickOpt timing cycle optimization - a programmer-based optimization method that is proprietary to St. Jude that is used with CRT-Ds, CRT-Ps and ICDs to help physicians quickly program the device's timing cycles – in about 90 seconds – to help deliver optimal therapy to patients.

DeFT Response technology – designed to help devices meet the needs of patients with high or varying defibrillation thresholds, helping physicians to ensure appropriate delivery of life-saving therapy.

VIP (Ventricular Intrinsic Preference) algorithm – provides a delay in device stimulation of the lower chambers of the heart (ventricles) to allow the patient's own heart rhythm to prevail when possible. The VIP technology is designed to provide device stimulation only when needed, which has been shown to be better for patients overall heart health, St. Jude noted.

SenseAbility technology – designed to enable physicians to program the device to more accurately sense abnormal heart rhythms, thereby protecting the patient from receiving inappropriate shocks.