News | January 04, 2013

VerifyNow II System Gains European CE

Clinical data, guideline recommendations and cost effectiveness study strengthen clinical need for platelet reactivity testing

Accumetrics VerifyNow II CE mark Antiplatelet Therapy

January 4, 2013 — Accumetrics Inc. announced that its next generation VerifyNow II System has achieved CE marking for point-of-care measurement of platelet reactivity to antiplatelet agents. This marks the culmination of a series of important milestones in 2012, increasing evidence of the clinical value of platelet reactivity testing and significantly expanding the market opportunities for the VerifyNow System in both surgical and Interventional cardiology patient populations.

The next generation system, the VerifyNow II product line, received CE mark and will launch in Europe starting early this year. The advanced system includes upgraded features and state of the art user interface that promise to further increase penetration in markets in the European Union. Future worldwide geographies are planned for introduction in 2013.

In 2012, new guidelines from the Society of Thoracic Surgery (STS) recommended platelet reactivity testing for surgical patients in order to better manage patients’ response to antiplatelet medications. These guidelines include a new Class II recommendation for patients who require urgent surgery to help determine the risk of bleeding and the timing of surgery. In the area of interventional cardiology, the much-awaited results of the 8500+ patient ADAPT DES trial were also presented at the annual Transcatheter Cardiovascular Therapeutics conference, validating the association between high platelet reactivity and one-year patient outcomes

”There have been large strides in 2012 towards solidifying the clinical role of platelet reactivity testing,” said Matthew J. Price, director of the Cardiac Catheterization Laboratory at Scripps Clinic, La Jolla, Calif. “We now have large trials and registries validating the risks associated with high platelet reactivity in PCI patients and increased data and stronger guideline recommendations for use of platelet reactivity testing to aid in determining surgical timing. Physicians can now implement platelet reactivity testing in multiple clinical settings to provide valuable information to aid in making treatment decisions for the millions of patients requiring antiplatelet agents.”

Increased focus on the cost effectiveness of platelet reactivity testing also fuelled market expansion in the United States in 2012. The availability of generic clopidogrel, along with the launch of Medicare’s 30-Day Readmissions Reduction program, raised awareness of the key role of platelet reactivity testing in supporting cost effective and clinically appropriate decision making.

“As the clinical role of platelet reactivity testing continues to gain traction in the interventional cardiology marketplace, we are pleased to see additional clinical specialties, such as surgery and interventional neuroradiology, demonstrate an increased need for platelet reactivity testing as well,” said Timothy I. Still, president and CEO of Accumetrics. “Plavix losing its patent in the United States, the inclusion of platelet reactivity testing in the recent surgical guidelines, and the availability of new medical devices that require the use of antiplatelet therapies, continue to offer new growth opportunities for our company. As the leader in platelet reactivity testing, we remain focused on producing high quality diagnostic tests that provide critical information to physicians to help improve the quality of care for patients on these life-saving antiplatelet agents.

The VerifyNow System is currently used in over 800 facilities in the United States and over 70 countries worldwide where antiplatelet medications are prescribed to reduce the occurrence of future thrombotic events such as heart attack and stroke.

Test is indicated outside the United States for evaluating the risk for recurrent events in cardiovascular patients.

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