St. Jude Medical, Inc. 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.