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St Jude Medical's Epicor LP Cardiac Ablation System receives CE Mark and US FDA clearance

St Jude Medical : 19 August, 2008  (New Product)
St Jude Medical has received European CE Mark approval and US Food and Drug Administration clearance for the Epicor LP Cardiac Ablation System, which is a second generation technology that uses HIFU (high intensity focused ultrasound) to surgically ablate cardiac tissue to disrupt abnormal electrical impulses in the heart.
The first patient to undergo treatment with the Epicor LP System was a 73-year-old male with coronary artery disease and atrial fibrillation (AF). The procedure was performed by Malcom Dalrymple-Hay, FRCS PhD. FECTS, a cardiac surgeon at Derriford Hospital in Plymouth, United Kingdom. The patient, who has suffered from persistent AF for more than three years, had a normal heart rhythm upon completion of the ablation procedure.

'An increasing volume of published literature is demonstrating the benefits of treating pre-existing AF in patients who are undergoing valvular or coronary artery bypass surgery,' said Dr Dalrymple-Hay. 'The Epicor LP System provides me with a technology that is flexible enough to treat AF patients during either standard open chest procedures or minimally invasive surgical procedures.'

AF is the most common abnormal heart rhythm condition, affecting millions of patients worldwide. With AF, the heart's upper chambers (the atria) do not beat effectively due to abnormal electrical activity. As a result, the heart cannot effectively pump blood, which can lead to shortness of breath, heart palpitations and fatigue. If left untreated, AF increases the risk of stroke five fold, according to a study reported in the journal Stroke (Wolf et al, Atrial Fibrillation as an Independent Risk Factor for Stroke: the Framingham Study, 1991). AF is progressive and increases in frequency and severity as patients grow older, and surgical cardiac ablation has been found to provide relief from AF for a high percentage of patients.

In surgical ablation performed with a HIFU energy source, energy is focused from outside a beating heart. This treatment has been designed to create precise and complete lines of cardiac tissue ablation to block chaotic electrical impulses. The patient does not need to be placed on a heart-lung bypass machine nor is the heart stopped. Because HIFU energy is directed from outside the heart inward (instead of from the inside out as is sometimes the case in ablations performed with other energy sources), the risk of unintended peripheral damage is minimized.

In contrast, the traditional surgical approach requires that patients be placed on a heart-lung bypass machine with their hearts stopped while a cardiac surgeon cuts maze-like patterns in the atrial tissues and then sews the incisions to encourage the formation of lesions, or tiny scars. Surgeons may also use alternative energy sources, such as radiofrequency or cryothermy, to create lesions in heart tissue. The lesions disrupt the abnormal electrical impulses that cause AF.

The Epicor LP system has a lower profile (smaller relative to the first generation technology) as well as other features designed to facilitate easier device introduction and placement around and on patients' hearts. In addition, the Epicor LP System is equally suited for use in both closed-chest procedures performed through a single incision, and in open-chest procedures.

In the December 2007 edition of The Annals of Thoracic Surgery, the results of an independent investigator clinical trial led by Mark Groh, MD, showed that AF is effectively treated using the Epicor Cardiac Ablation System when used concomitantly to corrective heart surgery. The investigators reported that more than 83 percent of all patients, followed for at least six months after surgery, were free from AF. In addition, 86 percent of the patients followed for at least 18 months remained free from AF. The investigators reported that there were no device or ablative procedure-related adverse events and specifically noted an absence of esophageal, coronary or phrenic nerve damage.

The 2007 results confirmed the findings of an earlier European multi-centre trial published in the September 2005 Journal of Thoracic and Cardiovascular Surgery. The investigators in the European clinical trial reported an 85 percent freedom-from-AF rate at six months post-procedure - the study's primary efficacy end point - in patients concomitantly treated for AF with the Epicor Cardiac Ablation System.

St Jude Medical acquired Epicor Medical in 2004 and worked closely with Dr James Cox to develop the Epicor Medical HIFU ablation system and its related surgical procedure. Dr Cox is the developer of the Cox-Maze surgical procedure for the treatment of AF and is acknowledged by his peers as a pioneer in the field. Since the acquisition, St Jude Medical has been committed to improving the manufacturability and performance of the HIFU surgical ablation technology. St Jude Medical continues to pursue expanded clinical data, as well as additional tools to facilitate minimally invasive procedures, for the technology.

The first generation Epicor System gained regulatory approval for the treatment of AF in Europe in 2006. In the USA, the first generation Epicor System and the Epicor LP System received clearance from the FDA for the surgical ablation of cardiac tissue but have not been indicated by the FDA specifically for the treatment of AF.
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