Medicare Expands Coverage for LifeVest Wearable Defibrillator

July 13, 2005 - PITTSBURGH, PENNSYLVANIA - LIFECOR, manufacturer of the LifeVest, the world’s first wearable defibrillator, announced today that Medicare has expanded its coverage of the LifeVest for the prevention of sudden cardiac death. Coverage now includes more patients who have a sudden death risk, but who are not covered for an implantable cardioverter-defibrillator (ICD).

The new reimbursement policy now includes use for patients with an ejection fraction (EF) of less than 36 percent. These patients must also have had either a myocardial infarction (MI) or non-ischemic cardiomyopathy (NICM).

Sudden death is a well-known complication of MI, commonly known as a heart attack, and of NICM, a condition where the heart’s muscle becomes weak. Sudden death is particularly common when the EF, a measure of the heart’s pumping performance, is low. EF may rebound significantly, as the heart muscle heals after an MI, or after coronary artery bypass graft (CABG) surgery or angioplasty.

A recent paper in the June 23, 2005 issue of the New England Journal of Medicine (NEJM) notes that during the first 30 days after an MI, patients are most vulnerable to sudden death. After three months, the risk is reduced greatly and levels off. According to Scott Solomon, M.D., and co-authors, "[the] data provide a rationale for considering early interventional strategies, including short-term therapies, in selected patients at risk. This is supported by the fact that the majority of our patients (47 percent) who were resuscitated during the first 30 days were alive at 1 year."

An accompanying editorial to the NEJM paper notes that wearable defibrillators might offer protection to this patient population. Alfred Buxton, M.D., supported the Solomon’s study conclusions and suggested that one strategy to protect post-MI patients during the period of greatest risk would be to provide people leaving the hospital with a wearable defibrillator for a limited time. Dr. Buxton had no role in the VALIANT study or the retrospective analysis.

A common treatment for patients at risk of sudden death is ICDs. However, ICDs are designed for use over a long period and require surgery at considerable expense. In contrast, wearable defibrillators are intended for temporary use and may be rented on a monthly basis. Most health insurance, including Medicare, does not cover ICD implantation when the heart is recovering and its performance may improve, sometimes dramatically. The only Medicare-covered devices designed to prevent sudden death during this transition are wearable defibrillators.

According to Stephen Winters, M.D., Director of Cardiac Rhythm Management Program, Morristown Memorial Hospital, an arrhythmia expert and early adopter of wearable defibrillator technology, "These articles highlight the important issue of helping patients in the short-term. The LifeVest device is a great bridge to ICD implantation or reassessment of the patient’s condition. Patients readily accept the device and generally are very reassured once they receive the LifeVest. In my practice, we are encouraging widespread use of the LifeVest device for patients who have a low EF early after an MI."

About the LifeVest System
The LifeVest is the first wearable defibrillator, worn outside the body rather than implanted in the chest. The non-invasive device, which is worn under normal clothing and weighs only three pounds, continuously monitors the patient’s heart to detect life-threatening abnormal heart rhythms. If a life-threatening rhythm is detected and the patient is unconscious, the device delivers an electrical shock to restore normal rhythm, typically within one minute.

About LIFECOR
LIFECOR, Inc., based in Pittsburgh, Pennsylvania, is a privately owned company that manufacturers and markets the LifeVest wearable defibrillator, which is worn by a patient at risk for sudden cardiac arrest. Sudden cardiac arrest leads to death within a few minutes if not treated by an electrical shock from a defibrillator. The LifeVest device monitors the patient’s heart continuously and, if the patient goes into a lifethreatening heart rhythm, delivers a shock treatment to restore the patient’s heart to normal rhythm. LIFECOR’s current third-generation LifeVest was approved for sale in the United States by the FDA in October 2002. LIFECOR rents and sells the wearable defibrillator to hospitals and patients through a network of direct sales representatives and distributors in the United States and Europe.