ECP / EECP treatment is approved by USFDA
External Counter pulsation Therapy (also called ECP or EECP or CPT- Counter pulsation technology therapy) has been reclassified as a Class ii product by the food &Drug Administration for severe Angina not amendable to surgery. This comes as big news to the External Counter pulsation Therapy industry as the ECP and EECP devices have been categorized as a Class iii device. The U.S. Food and Drug Administration (FDA), Department of Health and Human Services, issued its final decision to reclassify ECP Therapy Devices for treatment of chronic stable angina for patients that are refractory to anti-angina medical therapy and without options for revascularization.
The Food & Drug Administration classifies medical devices into 3 Classifications to regulate medical devices intended for human use based on proven safety & efficacy from scientific evidence. The system established three classifications of devices that signify the degree of regulation needed to assure that the devices are safe and effective. The classifications include Class I for general controls, Class ii for special controls and Class iii for newer devices that require premarket approval or RMA to demonstration safety and effectiveness.
ECP or EECP Therapy has been proven to be an effective non-invasive treatment solution for patients that suffer from symptoms of coronary artery disease. ECP/ EECP Therapy is proven in nearly 200 published clinical trials to improve blood flow to the myocardium (heart muscle) by developing micro-vessel pathways around narrowed and blocked arteries.
The FDA’s reclassification of ECP devices is strictly for treatment of refractory angina that has been substantially proven in clinical research. The FDA’s move to reclassify the devices provides increased confidence of the evidence presented that ECP Therapy is a useful treatment option for this subset of patients. The ECP devices were previously classified as Class III.
There is more to this final decision to reclassify ECP Devices. The FDA included in its final ruling that other intended uses that were previously approved (unstable angina. Acute myocardial infarction, Cardiogenic shock and congestive heart failure) will require the filling of a PMA or complete a ‘ product development protocol ‘ (PDP) to maintain the previously cleared uses cleared (510(k)) procedure. In accordance with federal regulation, EECP Companies may continue to commercially distribute their devices for these intended uses for a period of 90 days after the issuance of the final order. The devices may continue to be marketed only for refractory angina if a PMA or a notice of completion of a PDP is not filed, Before the end of the 90-day period.
EECP Receives Class lla Recommendation in European Society of Cardiology Guidelines for Management of stable Coronary Artery Disease.
EECP (Enhanced External Counter pulsation Therapy) is give a lla Class of Recommendation in the 20136 European Society of Cardiology (ESC) Guidelines on the Management of Stable Coronary Artery Disease (SCAD). The Guidelines were released during ESC’s annual meeting which took place from August 31 to September 3, 2013 in Amsterdam, the Netherlands.
The Class IIa signifies high level of evidence in favor that physicians should consider Therapy as a treatment option for patients suffering chronic stable angina. The American College of Cardiology Foundation and The American Heart Association (ACCF/AHA) Task Force on Practice Guidelines retained the same IIb Class of Recommendation rating issued in the ACC/AHA 2002 Guideline Update for the Management of Patients with Chronic Stable Angina. The approval with the ESC represents a positive step towards upgrading EECP Therapy’s level of recommendation to IIa in its future guideline with the ACC / AHA Guidelines.
EECP is a safe & effective non-invasive solution proven to reduce re-hospitalizations and emergency room visits, Proponents of EECP Therapy believe this treatment should be available to a much wider patient base as it is a much safer, lower cost solution that provides substantial benefits to many medical ailments beyond Coronary Artery Disease.
EECP Therapy Maintains Class llb Rating with the new ACC/AHA Guidelines for Stable Ischemic Heart Disease (November 27th. 2012).
The American College of Cardiology Foundation and American Heart Association (ACCF/AHA) Guidelines issues practice Guideline every 10 years for treatment of specific heart disease conditions. The Guidelines for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease.
The outcome of the guidelines are significant. In the spirit of coast saving in the new Healthcare environment, there were significant changes in tone towards expensive healthcare procedures such as invasive surgical procedures as well as costly diagnostic imaging. Among the guidelines, there is an emphasis on non-invasive, non-surgical lines of treatment such as External counter pulsation Therapy. Among the results of the revision, EECP (trademarked term by Vasomedical for ECP) therapy retained the same class IIb recommendation (COR) rating it received in the ACC/AHA 2002 Guideline Update for the Management of patients with Chronic Stable Angina. EECP Therapy was also given a B rating for level of Evidence (LOE).
According to the Guideline, a class IIb rating maintains that procedures and treatments may be considered for patients. Additional studies with broad objective are needed and further registry data would be helpful. This classification finds that the benefits of treatments are greater than or equal to the risk of treatment. This report appears to represent positive new for ECP and EECP Therapy as this a safe, effective treatment option at a fraction of the cost of invasive, surgical treatment option. Healthcare cost reduction has been demonstrated in the clinical literature to reduce re-hospitalizations and emergency room visits. An additional note, EECP was the only treatment option of the three available alternative treatments for ischemic heart disease, including (spinal cord stimulation and transmyocardial revascularization) that maintained the same Class of Recommendation and Level of Evidence in the new Guideline as in the 2002 Guideline. The other two alternative treatments were given lower COR and / or LOE ratings than the 2002 Guideline. EECP is now listed as the first alternative treatment for ischemic heart disease and continues to hold an equal or greater level of acceptance in this important category.
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