Healthcare Industry News:  neuromodulation 

Devices FDA Cardiology

 News Release - August 18, 2008

St. Jude Medical Announces CE Mark Approval and FDA Clearance for New Family of HIFU Surgical Ablation Products

Patient at Derriford Hospital in the United Kingdom is the first to undergo treatment

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) has received European CE Mark approval and U.S. Food and Drug Administration (FDA) clearance for the Epicor™ LP Cardiac Ablation System, 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 Ph.D. 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, M.D., 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-center 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 U.S., 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.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 12,500 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K filed on February 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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