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WaveSense Diabetes Products Safe from Maltose Inaccuracy Risks

August 27, 2009

SALEM, N.H., Aug. 27 /PRNewswire/ — AgaMatrix, Inc., the makers of WaveSense blood glucose meters, announced today their continued commitment to educate health care professionals and patients on the importance of blood glucose meter (BGM) accuracy for all patients. WaveSense BGM’s uniquely employ WaveSense technology which personalizes each test to provide world class accuracy. They detect and correct for errors caused by different environmental conditions and blood samples.

According to an industry whitepaper, nearly 90,000 people use drugs or solutions(1), which put them at risk of death if they use some BGM’s that use different technology and give inaccurate results because they use the enzyme system GDH PQQ (glucose dehydrogenase pyrroloquinoline quinine). All WaveSense BGM’s employ a unique, patented technology, including a different enzyme, thus are not affected by this issue.

Products representing over 30% of the BGM market could be affected(2), spanning 18 different brands. The FDA has developed a complete list of these products: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm

Nancy D’Hondt, RPh, CDE, a nationally recognized diabetes expert from St. John Hospital and Medical Center states, “Patients with diabetes should not be put at risk by using meters that could render inaccurate results. Our patients often cannot remember which medications they take, let alone understand meter technology and capabilities. In emergency situations and in the healthcare setting, we rely more and more on accuracy and reliability using point-of-care testing devices, so eliminating the potential for error is a must, especially given that safer alternatives exist.”

Clinical data shows that WaveSense brand BGM’s are unaffected by maltose concentrations up to 120 mg/dL, twice the clinically relevant levels associated with peritoneal dialysis, according to Meg Wiley, Director of Clinical Affairs at AgaMatrix, makers of WaveSense diabetes products.

Falsely elevated blood glucose readings could occur when testing with BGM’s that use GDH PQQ. Several drugs and solutions (including OCTAGAM(R), Extraneal(R), D-Xylose USP(R)) used in peritoneal kidney dialysis or to treat immune deficiency diseases contain, or produce as a metabolite, sugars such as maltose, xylose, or galactose that react with GDH PQQ to provide results that are higher than the patient’s actual glucose level. This could result in unsafe treatment and consequent health risks.(3),(4)

About WaveSense Products:

WaveSense(TM) is a line of blood glucose meters, strips, and software designed to improve the quality of diabetes care by using a new technology that personalizes each test to provide world class accuracy. It detects and corrects for many errors caused by differences in blood samples and environmental conditions. Current AgaMatrix products include the WaveSense KeyNote(TM), Presto(TM), Jazz(TM), and the WaveSense Diabetes Manager iPhone App. WaveSense meters and strips are covered by insurance and available by mail order and at popular retail outlets such as Wal-Mart and Kroger. For more information, go to: www.wavesense.info.

(C) 2002-2009 AgaMatrix, Inc. WaveSense, KeyNote, Presto, Jazz, WaveSense Diabetes Manager are trademarks of AgaMatrix, Inc. iPhone, Wal-Mart and Kroger are registered trademarks of their respective owners.

(1) Industry whitepaper “Blood Glucose Monitoring: The Facts about System Limitations.”

(2) IVD market data, BBC Whole Blood Glucose Monitoring Report (2008)

(3) FDA: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm

(4) FDA: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm

SOURCE AgaMatrix, Inc.


Source: newswire



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