FDA clears first computer-aided device to assist in the detection of heart murmurs

Jun 2 2004

Zargis Medical Corp., a majority-owned subsidiary of Speedus Corp, announced today it has received U.S. Food and Drug Administration (FDA) clearance to market Zargis Acoustic Cardioscan (Cardioscan), the first and only computer-aided medical device to support physicians in analyzing heart sounds for the identification of suspected murmurs, a potential sign of heart disease.

"Zargis is the only company that has been able to achieve this significant milestone, which demonstrates our outstanding technical expertise and core competency in this clinically important field", said Zargis President and Chief Executive Officer, Shahram Hejazi, Ph.D.

"We are extremely pleased by this FDA clearance which helps pave the way for future Zargis products. It is our hope that Cardioscan, the first product of its kind, will become the new standard of care" said Silvano Dall'Asta, Zargis Director and CFO of Zargis partner, Siemens Corporate Research, Inc.

Cardioscan is easy to use, non-invasive, portable, and takes just minutes to perform. Developed by biomedical scientists from Siemens and Zargis over the past seven years, Cardioscan acquires, processes and analyzes heart sounds, then provides easily interpretable graphical and textual results to physicians. Using Cardioscan to identify suspected murmurs through the assessment of patients' heart sounds, physicians will have an added tool available to them in identifying the presence of murmurs that will assist them in their determination of whether further testing or specialized attention from a cardiologist is warranted. In addition, Cardioscan will provide an electronic and printable record of a patient's heart sounds, giving the physician a baseline, and an additional means by which to detect and track changes over time. Dr. Alvin J. Chin, MD, Professor of Pediatrics, University of Pennsylvania School of Medicine and Zargis advisor said, "I was most impressed with the Cardioscan prototype. It is simple, clean, elegant and will be a valuable decision support tool for most physicians".

Cardioscan will initially be launched to a select group of physicians, teaching hospitals and other health care professionals.

A clinical study utilizing data obtained from leading national medical centers including Children's Hospital of Philadelphia, Texas Heart Institute in Houston and St. Francis Medical Center in Roslyn, N.Y demonstrated the detection of heart murmurs by Cardioscan with a sensitivity of 91.8% and a specificity of 68.0%. A study published by the American Medical Association1 reported only 20% correctness among 450 internal medicine and family practice physician residents in identifying 12 basic heart sounds and murmurs. Listening to the heart with a stethoscope remains the most widely used method for the detection of heart murmurs. Cardioscan also achieved 91% sensitivity and at least 92% positive predictivity in the identification of S1 and S2, two dominant heart sounds in each heart beat that are important for the identification of heart murmurs. S1 is commonly referred to as the "lub" sound and S2 the "dub" sound.

Certain types of valvular and congenital heart disease are manifested by heart murmurs and proper interpretation is essential for accurate diagnosis and disease management. According to published studies, it is estimated that approximately 30% of the adult population, and up to 80% of children are affected by heart murmurs. Although only a small percentage of these murmurs result from heart disease, and even fewer are life threatening, the American Heart Association states that valvular heart disease affects more than 20 million people in the United States, while another 1 million Americans are living with congenital cardiovascular defects. Moreover, according to the same report, mortality for diseases of the heart that may be related to a murmur is in excess of 49,000 per year. "Cardioscan can be an important tool for aiding in the early identification and assessment of sounds that could signify heart disease," said Dr. Hejazi. "This device could provide doctors with a much needed tool to help them provide better care to their patients while optimizing the healthcare process."