Compelo Medical Devices - Latest industry news and analysis is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More
Close
Dismiss

B•R•A•H•M•S Submits MR-proANP Kryptor For FDA Approval

B•R•A•H•M•S Aktiengesellschaft announced that it has submitted 510(k) application to the US Food and Drug Administration (FDA) to market its patented B•R•A•H•M•S MR-proANP Kryptor Test. Atrial Natriuretic Peptide (ANP) is predominantly produced in the atrium of the heart and comprises 98% of the natriuretic peptides in the circulation. ANP is involved in natriuresis, diuresis, vasodilation and cardiovascular homeostasis. Although this peptide is unstable, the BRAHMS-assay detects the corresponding prohormone fragment: the Mid-Regional pro-Atrial Natriuretic Peptide (MR-proANP). In contrast to the material peptide, MR-proANP is a stable and reliable surrogate measurement of atrial natriuretic peptide levels. The clinical benefits of MR-proANP were analyzed within an international, multi-center, prospective, multi-marker trial called BACH (Biomarkers in Acute Congestive Heart Failure). Enrolling 1641 patients presenting with shortness of breath to participating emergency rooms the study demonstrated MR-proANP to be an excellent marker for diagnosing congestive heart failure. Furthermore it provides additional information especially in diagnostically challenging subgroups such as obesity, higher age or renal dysfunction to routinely used markers. Having been first presented at the 2008 ESC Congress the results of the BACH-trial confirm the company’s commitment to improving healthcare through highly effective biomarker tests and complement the success of the Procalcitonin Kryptor, the company’s test for the diagnosis of severe bacterial infections, introduced in the US in the first half of 2008.