ST. PAUL, Minn. & TOKYO. -- St. Jude Medical, Inc., a global medical device company, today announced the Japanese launch of the Unify Quadra™ cardiac resynchronization therapy defibrillator (CRT-D). The Unify Quadra CRT-D works with the company’s first-to-market Quartet™ left ventricular pacing lead to offer a small quadripolar pacing system that helps physicians effectively and efficiently manage the common challenges of patients with heart failure.

Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands. It results in the build-up of fluids throughout the body, which can lead to shortness of breath, swelling and heart rhythm abnormalities. The Unify Quadra CRT-D system was designed to help the heart perform in its most natural state by synchronizing the left and right ventricles of the heart through timed electrical pulses.

The quadripolar system integrates multiple pacing configurations and features that provide physicians with more options to better manage common pacing complications without exposing the patient to additional surgeries in order to reposition the lead. This is important because approximately one in 10 patients who receive a CRT system have complications that could require an additional surgery. To date, more than fifty publications have provided clinical evidence supporting the benefits of quadripolar technology to manage common pacing complications, enable better clinical efficiency and provide a greater opportunity for efficacy.

The Unify Quadra CRT-D works with the company’s Quartet left ventricular pacing lead. It features four electrodes, rather than the conventional two or less. The additional electrodes allow for multiple pacing configurations, which provide the physician with more pacing options. This includes the ability to pace closer to the base of the left ventricle, which research has consistently shown to provide better patient outcomes and can be difficult to achieve with the conventional two-electrode lead. The quadripolar pacing electrodes also allow physicians to avoid the most common kinds of pacing complications and to pace around scar tissue found in the heart.

Commenting on the technology, Dr. Morio Shoda, associate professor, Department of Cardiology at Tokyo Women’s Medical University said, "The Unify Quadra is a technological advance for patients that need cardiac resynchronization therapy. With quadripolar technology, I have more pacing options available, which improves the probability for successful response to the therapy."

Complications can arise after placing the lead of a CRT device because of individual patient anatomy or because they are body position sensitive and may not be evident while patients are lying on their back during the implantation procedure. One example of a pacing complication is a high pacing threshold. Patients who already have scar tissue formed in the heart, possibly as a result of a previous heart attack, may require additional energy from their CRT device, which can wear out the battery more quickly. Another complication that can result is the unintentional stimulation of the diaphragm from pacing the phrenic nerve, which results in hiccup-like symptoms. The Quartet lead’s four electrodes can help avoid these complications by providing physicians more options to choose alternative pacing sites without having to relocate the lead either during or with a second surgery.

Because the physician can non-invasively adjust pacing locations or configurations, the technology has the potential to reduce patients’ risk of needing multiple surgeries. This is important because some complications, such as phrenic nerve or diaphragmatic stimulation, are body-position sensitive and may not be evident until after the patient leaves the hospital.

"The many benefits of quadripolar pacing have been demonstrated by implanters around the world and reported in a large number of published studies. We are pleased to now have it available in Japan," said William Phillips, president of St. Jude Medical Japan. "We believe that this small and innovative CRT system has the potential to redefine the standard of care in resynchronization therapy for heart failure patients."

The Unify Quadra uses the new International Standards Organization (ISO) DF4 and IS4 connector specifications to further streamline the procedure. The DF4 connector reduces the number of connections between the defibrillation lead and the device, which can help improve patient comfort by reducing the bulk of wires in a patient’s chest. The IS4 connector enables four electrodes to be used on the Quartet left ventricular pacing lead while connecting to a single standard connector on the Unify Quadra device.

Source: St. Jude Medical, Inc.