FDA Meeting of Circulatory System Device Panel scheduled for December 5th, 2012 to evaluate use of ECP Therapy
The Food & Drug Administration is holding a meeting on December 5th, 2012 with the Circulatory System Device Panel to discuss 5 key components related to the use External Counterpulsation Therapy (ECP) Devices in the United States.
The 5 Points of Evaluation include:
- Health Risks that can possibly occur from ECP device during Treatment
- Is ECP effective enough to undergo treatment despite (manageable) health warnings?
- Proper labeling about safety of ECP device operation including inflation/deflation timing, electromagnetic compatibility (EMC), device reliability/ malfunction, skin contact components (cuffs) bio-compatible.
- Does evidence exist to maintain current ‘Indications of Use’ (other than Chronic Stable Angina) such as unstable angina, cardiogenic shock, acute myocardial infarction & congestive heart failure?
- FDA Device Classification and more ‘Indications of Use’ in addition to chronic stable angina
This meeting is significant to the healthcare industry and patient access & eligibility of External Counterpulsation Therapy (ECP or also referred to as EECP). To those knowledgeable about ECP have seen first hand the positive outcomes delivered to hundreds of thousands of patients here in the U.S since Medicare began coverage in 1998.
It is important to note before we detail the items of the December 5th meeting of the FDA panel, that on November 27th of 2012, Vasomedical received notification by the ACC / AHA Guidelines for Ischemic Heart Disease that the classification and Level of Evidence ratings were maintained. This is significant in that it further proves that the task force on Cardiovascular Disease is in agreement that External Counterpulsation Therapy (a Class IIb device) is a safe and effective treatment option for patients that suffer from symptoms of Ischemic Heart Disease (such as chest pain, shortness of breath and chronic fatigue). The other alternative treatments such as Transmyocardial Revascularization and Spinal Cord Stimulation were downgraded due to lower, less qualified classifications making ECP treatment the first line of alternative treatment options besides invasive surgery procedures. For more information, see our summary below or visit News Wire.
To those patients, physicians and other medical professionals with ECP experience, virtually all of us can unanimously concur that External Counterpulsation Therapy is a very safe, effective treatment that brings tremendous benefits to all aspects of the body’s health including the treatment of chronic stable angina.
The mechanical process of ECP acts as a circulatory assist system that physically delivers oxygenated blood to ALL parts of body including the coronary arteries for chronic angina. As we all know, the progression of ischemic heart disease affects all parts of the body’s function in addition to the heart. ECP is an effective modality that can help restore this blood flow and prevent or significantly slow the progression of more blockages (much like physical exercise). ECP is proven repeatedly in clinical trials to have much of the bi-products (benefits) of intense physical exercise in that it improves endothelian function, release of nitric oxide, promotes collaterization, with improvements in cardiac function (contractility) The increased perfusion is known to promote or stimulate growth and revive tissue that has deteriorated over time from a lack of adequate blood flow.
ECP is already proven to be a clinically effective treatment option for patients with advanced coronary artery disease at a substantially lower cost compared to invasive treatment options. At a time when Healthcare costs are on the forefront, ECP should be considered as a treatment option for other classifications for Angina (such as Class II Angina) because it is a safe, effective, lower cost option that will not only reduce current healthcare costs, but also reduce future healthcare costs to patients those prone to the advancement of ischemic disease. Further, it is well known that exercise is recommended by virtually every physician in the U.S, ECP should be considered a viable treatment procedure for elderly patients that are physically incapable to exercise due to disability, or to those that have neglected their health for many years to get ‘head start’ to getting their health back on the right course. As we all know, an inactive lifestyle leads to a whole array of medical ailments which result in a financial burden to our health care system.
Another aspect that should be strongly considered is the level at which patients can have access to ECP treatment. A patient suffering with symptoms of chest pain on the primary care level cannot currently be prescribed by their regular physician but only through a Cardiologist. Once a patient gets to a cardiologist, there is a high probability that the net result is usually another angiogram/stent or even bypass surgery. If this same patient was offered ECP on the primary care level, the symptoms could likely be reduced while avoiding the patient risk, the healthcare expense & necessity of the surgical procedure. Of course this would not always the case, but could be common among Class II Angina patients. The ‘status quo’ is (without question) a significant cost burden of our healthcare system. The addition of of class II angina and the freedom of any level physician to prescribe ECP treatment will reduce patient symptoms, reduce hospital admissions and prolong the advancement (progression) of heart disease that always leads to more expensive treatment such as bypass surgery or angioplasty / stents.