Siemens Receives FDA Clearance of the Xprecia Stride™ Coagulation Analyzer

Siemens Healthineers has more than 30 years of central lab hemostasis leadership. Building on to its portfolio, the company announced today FDA 510(k) clearance for a hand-held portable coagulation analyzer. The Xprecia Stride Coagulation Analyzer delivers fast, reliable Prothrombin Time International Normalized Ratio (PT/INR) testing for point-of-care monitoring and management of oral anticoagulation therapy with warfarin, a vitamin K antagonist.
Millions of PT/INR tests are administered world-wide each year as
part of therapy monitoring for patients with a host of conditions,
including atrial fibrillation, heart valve replacement surgery, deep
vein thrombosis and congenital heart defects, among others. The Xprecia
Stride Coagulation Analyzer was specifically designed to meet the
growing demand for fast and reliable PT/INR results in physician offices
and walk-in clinics to help healthcare professionals make informed
decisions about patient care.
Winner of multiple international design awards such as the Red Dot
Award: Product Design for 2015 and the iFDesign Award, the analyzer
includes a number of innovations and features not found on most other
point-of-care analyzers. No bigger than a smartphone and weighing just
10.5 oz, the Xprecia Stride Coagulation Analyzer can be held at
virtually any angle and brought directly to the patient’s finger for
efficient and comfortable blood sample application.
“Among the many challenges of point of care testing, accuracy and safety
have become paramount to both the user and patient. With the Xprecia
Stride analyzer, Siemens Healthineers delivers on the promise to bring a
safe and lab-accurate test directly to the patient,” said Michael
Sampson, Senior Vice President, Point of Care, Siemens Healthineers,
North America. “The Xprecia Stride analyzer is designed to be safe,
efficient and ergonomically friendly. By adding the Xprecia Stride
analyzer to our existing product portfolio in the U.S., we now have the
ability to cover the full range of hemostasis testing from the hospital
lab to the physician’s office.”
Today’s busy healthcare professional is challenged by a complex work
environment and heavy patient workflow. The Xprecia Stride analyzer was
designed to address these concerns through an intuitive user interface
and features such as an integrated barcode scanner to simplify data
capture and improve patient workflow. To further enhance usability, the
Xprecia Stride features simple icons and animation in a color display
more commonly found in mobile devices than medical instruments.
The Xprecia Stride analyzer uses fresh capillary (fingerstick) whole
blood and results are expressed as INR. It utilizes the same Dade®
Innovin® reagent used by Siemens Healthineers central lab analyzers to
minimize any potential for variability. Studies have shown the
performance to be equivalent to a reference laboratory hemostasis system,¹
with results available within minutes.
Safety features include a first-of-its kind test strip eject button that
allows the user to eject a used test strip and easily dispose of it
without touching it, minimizing potential biohazard exposure.
When taken together, all of these innovations ultimately enable better
patient care as point-of-care PT/INR testing becomes critical to
healthcare providers managing the growing number of patients that
require anticoagulation therapy.
¹ White Paper, Fernando R, Jacobson AK, Kennedy S, Lessard C, Olson K,
Scribner A, “PT/INR Test Performance of the Xprecia Stride Coagulation
Analyzer Demonstrates Equivalency with Established Laboratory Hemostasis
and Point-of-care Methods”
For further information on the Xprecia Stride Coagulation Analyzer,
please visit: www.siemens.com/xprecia
Follow us on Twitter at: www.twitter.com/SiemensHealth
Siemens AG (Berlin and Munich) is a global technology powerhouse that
has stood for engineering excellence, innovation, quality, reliability
and internationality for more than 165 years. The company is active in
more than 200 countries, focusing on the areas of electrification,
automation and digitalization. One of the world’s largest producers of
energy-efficient, resource-saving technologies, Siemens is No. 1 in
offshore wind turbine construction, a leading supplier of gas and steam
turbines for power generation, a major provider of power transmission
solutions and a pioneer in infrastructure solutions as well as
automation, drive and software solutions for industry. The company is
also a leading provider of medical imaging equipment – such as computed
tomography and magnetic resonance imaging systems – and a leader in
laboratory diagnostics as well as clinical IT. In fiscal 2015, which
ended on September 30, 2015, Siemens generated revenue of €75.6 billion
and net income of €7.4 billion. At the end of September 2015, the
company had around 348,000 employees worldwide. Further information is
available on the Internet at www.siemens.com.