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FDA marketing green light for SJM’s quadripolar pacing system

The FDA has given St Jude Medical the go-ahead to market its Unify Quadra cardiac resynchronisation therapy defibrillator (CRT-D) and Quartet left ventricular quadripolar pacing lead. The company will begin shipping the products to its salesforce to begin providing to customers immediately.

Collectively, the Unify system offers physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. It integrates multiple pacing configurations and Tailored Therapy features that enable physicians to use the system at implant and follow-up, as well as better manage common pacing complications without having to surgically reposition the lead. The system is also approved for remote patient management using the Merlin.net patient care network.

The Quartet lead, used as part of the Unify Quadra system, features four electrodes spaced over 4.7 cm, enabling up to ten pacing configurations. A number of pacing configurations allow the physician to implant the lead in the most stable position without making trade-offs in electrical performance. This includes pacing closer to the base of the left ventricle, which recent studies associate with better patient outcomes and which may be more difficult with traditional bipolar leads. The quadripolar pacing electrodes also provide physicians more options to monitor CRT performance, such as pacing around scar tissue in the heart and avoiding the most common pacing complications.

Heart Hospital of Austin, Texas

The first US implant of the device has taken place at  the Heart Hospital of Austin in Texas. Dr David R. Tschopp , director of electrophysiology at Heart Hospital of Austin , implanted the Unify Quadra quadripolar pacing system to regulate and resynchronise the heartbeat of a heart failure patient. The patient was diagnosed with non-ischaemic dilated cardiomyopathy, a condition resulting in decreased blood supply due to the heart’s main pumping chamber being enlarged, dilated and weak. Unify Quadra was determined to be the best fit because of the patient’s condition and the device’s ability to optimise the delivery of therapy.

Common pacing complications that can occur in patients implanted with a CRT system include high pacing thresholds and unintentional phrenic nerve or diaphragmatic stimulation. Patients with high pacing thresholds require significantly higher energy to pace the heart, which may reduce the device’s battery life requiring patients to have more surgeries to replace devices or cause pacing to be ineffective. Phrenic nerve and diaphragmatic stimulation also occur when the electrical output from a device inadvertently activates the diaphragm muscle, causing patients to hiccup with the delivery of the pacing stimuli. Both conditions are often due to the location of the pacing lead electrode and, with limited pacing options, may require that the lead be repositioned surgically or CRT be disabled.

Articles source, Cardiovascular Device Business



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