Siemens Receives FDA Clearance of the Xprecia Stride™ Coagulation Analyzer
October 04 2016 - 2:43PM
Business Wire
- The Xprecia Stride is a truly
handheld portable analyzer for any professional point-of-care
setting
- Features such as an integrated
bar-code scanner, hands-free strip disposal and intuitive
navigation promote safety, accuracy and ease of use
- The Xprecia Stride is the first POC
PT/INR device cleared by FDA based on the new rules published in
March 2016
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161004006486/en/
Siemens HealthineersKimberly Nissen,
610-448-6355Kimberly.Nissen@siemens.com
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