Healthcare Industry News: neuromodulation
News Release - January 25, 2008
Independent Clinical Trial Finds HIFU Surgical Ablation Effective in Treating Atrial FibrillationAnnals of Thoracic Surgery publishes results showing 83 percent efficacy rate
ST. PAUL, Minn.--(HSMN NewsFeed)--An independent investigator clinical trial has shown atrial fibrillation (AF) is effectively treated using the Epicor™ Cardiac Ablation System, when treated concomitantly to corrective heart surgery. The trial results were published in the December edition of The Annals of Thoracic Surgery. St. Jude Medical, Inc. (NYSE:STJ ) manufactures and distributes the Epicor system.
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 clinical trial is the first in the U.S. to examine the safety and efficacy of high-intensity focused ultrasound (HIFU) therapy for the treatment of AF. The prospective trial was conducted from February 2005 to February 2007 at Mission Hospitals in Asheville, N.C. A cohort of 129 patients (who had an ablation performed concomitant to another, already-scheduled cardiac procedure and who were followed at least six months) were assessed in the study. Freedom-from-AF rates were determined through rigorous post-operative physical examinations, electrocardiogram testing, and 24-hour Holter monitoring at six, 12 and 18 months post-ablation.
The results confirmed the findings of a 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.
“Recent published reports point to a strong justification to treat AF at the time of other cardiac surgeries in an attempt to improve the long-term patient outcomes of those procedures,” said Mark A. Groh, M.D., the lead investigator of the study. “Our study indicates that ablation using high intensity focused ultrasound can provide a safe and effective option for AF treatment during other heart surgeries.”
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. AF is progressive and increases in frequency and severity as patients grow older.
Surgical cardiac ablation has been found to provide relief from AF for a high percentage of patients. However, the traditional (non-HIFU) 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 conventional energy sources, such as radiofrequency, laser or microwave, to create lesions in specific heart tissue. The lesions disrupt the abnormal electrical impulses that cause AF.
In surgical ablation performed with a HIFU energy source, energy is focused from outside a beating heart 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.
The HIFU ablation device used in the study, the Epicor Cardiac Ablation System, is manufactured by St. Jude Medical. It has received clearance from the U.S. Food and Drug Administration (FDA) for the surgical ablation of cardiac tissue, but it has not been indicated by the FDA specifically for the treatment of AF. The Epicor System gained regulatory approval for the treatment of AF in Europe in 2006.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit www.sjm.com.
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 Company’s Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). 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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