Medical Compression Systems Receives FDA Clearance for New 'Prevention and Detection' Product
WEST HILLS, California, May 31, 2011 /PRNewswire/ -- Medical Compression Systems (MCS), which is involved in the non-invasive medical device industry and traded on the TASE, announced today that it has received FDA clearance to market the ActiveCare+Dx (temporary name) device developed on the basis of its flagship product, ActiveCare+S.F.T.(R)
The new product is the only one on the market which integrates venous obstruction prevention and detection capacities whereby both operations are carried out simultaneously during prophylactic therapy. This device detects venous obstructions in the patients' circulation whilst they occur and alerts about their formation. Currently, there is a 5%-6% risk of DVT formation amongst post-orthopedic surgery patients undergoing preventive drug or device therapy or a combination of the two. However, there is no drug or technology that has the capability to alert on prevention failure, which as stated above, occurs in 5%-6%. Using MCS's device will allow quicker identification of these patients and earlier treatment to begin, immediately after the presence of a blood clot is verified. Starting the therapy early could substantially reduce the occurrence of possible serious risks such as pulmonary embolism, which could be fatal.
The advantages of the company's flagship product, ActiveCare+S.F.T., over the leading DVT prevention drug, Lovenox, have already been proven in a multicenter clinical trial that was conducted by MCS on hip replacement patients in the US. The new device provides another advantage for MCS over the use of medication by providing early detection of those patients in whom preventive treatment has failed.
According to Adi Dagan, MCS CEO: "We are happy to receive FDA clearance for ActiveCare+Dx. This product meets a significant need, especially in the market of DVT prevention, where complications could be fatal. About ninety percent of the DVT cases are invisible and will not be diagnosed until clinical signs and symptoms are already presented. Their first presenting symptom can be pulmonary embolism or death. The product is expected to enter the market during the course of 2012."
About Medical Compressions Systems (MCS)
Medical Compression Systems (MCS) is a leader in innovative, non-invasive solutions for the prevention of venous thromboembolism (VTE). The company is the first and currently the only to offer the healthcare market a new class of proven Continuous Enhanced Circulation Therapy in combination with MCS's patented Synchronized Flow Technology (C.E.C.T.(R) + S.F.T.) devices that can replace pharmaceutical therapy as the current standard of care.
The company's products have US FDA clearance and are CE approved; its products are protected by numerous patents.
Founded in1997, MCS Medical Compression Systems (Ltd.), is an Israeli public company, traded on the Tel Aviv Stock Exchange (TASE: MDCL). MCS Inc., the company's subsidiary, is located in the USA.
Forward looking information
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SOURCE Medical Compression System Ltd