SOMTÉ RECEIVES APPROVAL BY EUROPEAN UNION TO MARKET
Compumedics Ltd., (ASX: CMP) , the Australian-based medical technology company today announced it had received approval by the European Union to market its recently released “Somté” sleep-cardiology recording system.
“This is a major milestone for both Compumedics and healthcare providers worldwide,” Mr. David Burton, executive chairman of Compumedics said today.
“For the first time, physicians will have a cost effective tool which will allow for quick diagnosis in the home and clinic for effective therapy of heart disease associated with sleep disordered breathing. Achieving the European Union CE Mark will immediately allow Compumedics to sell the Somté into the European medical arena,” he said.
Compumedics’ Somté is a first of its kind, lightweight medical recorder that combines features of diagnostic sleep systems and cardiac holter recorders. Somté is a very small (200 gram) device that records many standard sleep parameters (flow, chest and abdominal effort, oxygen saturation, and snoring) and standard holter-type ECG data. Software included with the Somté provides an automatic analysis of both respiratory and cardiac data, producing a comprehensive overview of the patient’s condition.
The device, which would be utilized by the patient on an overnight basis at home, provides information that will allow for early detection of cardiac dysfunction.
In Australia, the number of people treated at sleep clinics has jumped 25 percent to 43,400 in the past two years. Compumedics has 70% of the Australian sleep disorder diagnosis market and is fast growing its US market.
“It has been estimated that there are between 18 and 25 million people in the United States that have some form of sleep disordered breathing, such as sleep apnea (OSA),” Mr. Burton said.
“The correlation between sleep disordered breathing and cardiovascular disease has become very apparent. While the jury is still out relating to direct causative effect, there is no doubt that patients that exhibit sleep disordered breathing are at a very high risk of developing cardio-vascular disease (CVD) and congestive heart failure (CHF).
“CVD costs the United States $274 billion each year, including health expenditures and lost productivity. About 58 million Americans (almost one-fourth of the nation’s population) live with some form of cardiovascular disease. Available data indicate that heart failure may cost the US health care system as much as $36 billion annually. More than one million hospitalizations each year are directly related to CHF.”
Burton said Compumedics is helping to meet this challenge with a world-leading project involving the integration of a quality heart-holter and obstructive sleep apnea monitoring and analysis device in conformance to international clinical standards.
He said Compumedics had been approached by several leading internationally renowned research institutions to help solve the dilemma of escalating health care costs associated with treatment of patients with heart disease associated with sleep disordered breathing.
New evidence in the medical literature indicates that heart rate variability is altered in patients with sleep-disordered breathing. This alteration is evident even in the absence of hypertension, heart failure, or other disease states and may be linked to the severity of the breathing disorder. Abnormalities in heart rate variability may be implicated in the subsequent development of overt cardiovascular disease in patients with OSA.
“Clearly, an early detection of OSA as a precursor of cardiovascular disease would allow for the earliest and least costly intervention. Added to the fact that this study could be done at home and could be done without the need for expensive hospitalization, the end result would be a reduction in the overall cost of care of the patient,” Mr Burton said.
The increasing incidences and increasing costs associated with the care of patients with cardiovascular disease, congestive heart failure, and sleep disordered breathing reported in the United States, Europe, and other countries has been causing concern amongst health care professionals.
For example, cardiovascular disease, principally heart disease and stroke, is the leading killer for both men and women among all racial and ethnic groups in the United States and Europe. More than 960,000 Americans die of CVD each year, accounting for more than 40% of all deaths.
Heart disease is the leading cause of premature, permanent disability among working adults. Stroke alone accounts for disability among more than one million people nationwide. Almost 6 million hospitalizations in the United States alone each year are due to cardiovascular disease. Congestive heart failure, one form of cardiovascular disease which represents the end-stage of a number of different cardiac diseases, is the single most frequent cause of hospitalization for people aged 65 years or older.
“It has become clear that sleep apnea has serious cardiovascular effects when left untreated. As CVD and CHF rates continue to grow and the causative relationship of OSA becomes more apparent, the potential cost impact on the current healthcare delivery systems could be devastating,” Mr. Burton said.
“The CE approval of the Compumedics Somté device is a major step in solving this obvious dilemma. “Given the healthcare resources currently available in Europe and the United States, the healthcare delivery system would have a very difficult time coping with the cost of so many new patients.
“While it is obvious that in the long term there would be a decrease in the cost of care for these patients, the immediate effect could be a huge near term financial burden on third party payers such as Medicare.
“It is clear that the current method of diagnosing and treating these patients with expensive laboratory evaluations would quickly become too costly. The development of simple screening tools, like the Somté, to provide for the early and accurate detection of CVD in association with OSA for use by both specialists and non-specialist could represent a major development in cost effective care of these patients,” Mr. Burton said.
US FDA submission for 510(k) marketing approval will be made in April 2002.