CHELMSFORD, MA--ZOLL® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced today that the American Heart Association (AHA), with the endorsement of the Heart Rhythm Society (HRS), has issued a Science Advisory providing recommendations for use of the wearable cardioverter defibrillator (WCD) in clinical practice. The AHA and HRS recommend that the WCD may be considered for a wide range of patients at risk of sudden cardiac death (SCD), including those who have recently suffered a myocardial infarction (MI), with or without revascularization, and those with a newly diagnosed non-ischemic dilated cardiomyopathy.
The LifeVest® Wearable Defibrillator was approved by the Food and Drug Administration (FDA) in 2001. Since that time, the LifeVest has been worn by hundreds of thousands of patients globally and has saved thousands of patients’ lives.
As part of the development of the Science Advisory, clinical studies of the WCD were reviewed based on a search of published literature that was completed at the end of 2013. Based on that timing, the review was not able to include the results from the Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II) Registry of 2,000 WCD patients in the United States that was published in late 2015.
The WEARIT-II authors concluded that the WCD demonstrated both safety and efficacy in this large patient cohort with ischemic, non-ischemic, and congenital or inherited heart disease.1 The authors found the results demonstrated a high rate of sustained VT/VF at three months in at-risk patients.1 The authors also found that compliance with wearing the WCD was very high, and unrelated to disease etiology.1 ZOLL will continue to provide financial support for clinical studies, like WEARIT-II, to provide the physician community robust data to select patients that will benefit from a wearable defibrillator.
“We are very happy that the American Heart Association, with endorsement by the Heart Rhythm Society, has published comprehensive recommendations for WCD use by cardiovascular healthcare professionals. The AHA recommendations are very similar to those in the European Society of Cardiology Guidelines for WCD use published in late 2015,” said Jason T. Whiting, President of ZOLL LifeVest. “The implementation of these recommendations into clinical practice will save even more patients’ lives from sudden cardiac death.”
On any given day, tens of thousands of people around the world are protected from SCD by the LifeVest. The LifeVest is used for a wide range of patient conditions or situations, including following a myocardial infarction, before or after coronary revascularization, and for those with cardiomyopathy or congestive heart failure that places them at particular risk. The LifeVest gives physicians time to optimize medical therapy and assess a patient’s long-term risk for sudden death.
The LifeVest is lightweight and easy to wear, allowing patients to return to their common activities of daily living, while having the peace of mind that they are protected from SCD. The LifeVest continuously monitors the patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm.
The LifeVest is covered by most health plans in the United States, including commercial, state, and federal plans.