Spinal Cord Stimulation Pilot Study for Chronic Angina

Article ID: 527685

Released: 28-Feb-2007 9:00 AM EST

Source Newsroom: St. Jude Medical

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Newswise — St. Jude Medical, Inc. (NYSE:STJ) today announced the first patient implant in a pilot study that will preliminarily evaluate if stimulating nerves near the spinal cord will control chronic chest pain caused by angina.

A 53-year-old Massachusetts woman is the first person to receive this investigational device, called the Genesis® Neurostimulation System. She is one of approximately 1.3 million Americans who suffer from chronic angina, according to the American Heart Association (AHA), with 75,000 new cases of treatment-resistant angina occurring each year.

The Genesis System was developed by St. Jude Medical's neuromodulation division, Advanced Neuromodulation Systems (ANS).

"There are an increasing number of patients with coronary artery disease who have exhausted available medical and surgical treatment options," said Roger Laham, M.D., interventional cardiologist with Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, Mass., who is the principal investigator for the trial. "These patients struggle with disabling angina and are commonly referred to as 'no-option' patients."

"The procedure went smoothly," said Thomas Simopoulos, M.D., interventional pain specialist with the Arnold Pain Management Center at Beth Israel Deaconess Medical Center, who performed the implant. "I am hopeful that spinal cord stimulation will offer a minimally invasive treatment option for patients with chronic, intractable angina."

Angina is chest pain or discomfort that occurs when the heart muscle does not get as much oxygen as it needs. The pain is often described as a squeezing pain in the chest, shoulders, arms, neck, jaw or back and is sometimes described as feeling like indigestion. Angina is one of the most common symptoms of coronary artery disease which is a leading cause of death in the U.S.

Chronic angina is chest pain that persists. Many with this condition have to live with constant or recurring pain and loss of function. For a number of these people, medications such as nitroglycerin do not work, and surgical procedures such as angioplasty, stenting or bypass, are considered to be too risky by their doctors.

"The angina clinical trial is an important step forward in our commitment to provide pain solutions for people who don't have a lot of other options," said Chris Chavez, president of ANS.

Spinal cord stimulation (SCS) is a therapy that uses mild electrical pulses from an implanted device to stimulate targeted nerves. An SCS device looks and operates much like a cardiac pacemaker, except that instead of sending pulses to the heart, it sends them to leads located near the spinal cord. In this trial, SCS is being tested to see if it interrupts angina pain signals.

To be eligible to participate in the chronic angina pilot study, patients must be 18 years of age or older, have been diagnosed with inoperable coronary artery disease, and be experiencing a minimum of five angina episodes per week. Patients must also be diagnosed with functional class III or class IV angina, categorized according to the Canadian Cardiovascular Society (CCS) scale.

The study, a controlled, masked pilot, is being conducted under a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) in Boston, Mass.

For information about this clinical study, please contact ANS at 1-888-859-0008 or visit http://www.PowerOverAngina.com.

About ANS, the Neuromodulation Division of St. Jude Medical

Advanced Neuromodulation Systems is an innovative technology leader dedicated to the design, development, manufacturing and marketing of implantable neuromodulation systems to improve the quality of life for people suffering from disabling chronic pain and other nervous system disorders. Based in Plano, Texas, ANS (www.ans-medical.com) is a division of St. Jude Medical.

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 more than 11,000 people worldwide. For more information, please visit http://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 Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and in the Company's Quarterly Reports on Form 10-Q filed on August 7, 2006 (see Item 1A on page 32) and November 7, 2006 (see pages 31-32). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance


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