Tensys Medical Receives CE Mark for TL-400 & TL-300, Latest Generations in Continuous, Non-Invasive Hemodynamic Patient Monitoring System
SAN DIEGO--(BUSINESS WIRE)-- Tensys Medical, Inc., a leader in the development and commercialization of continuous, non-invasive hemodynamic patient monitoring systems, has received CE Mark for both the TL-400 & TL-300, the company’s latest generation systems. This will allow immediate commercialization of the systems throughout Europe. The TL-400 is a new member of Tensys’ established T-Line family, which has successfully been used by over 50,000 patients since commercial launch. In addition to capturing a patient’s beat-to-beat waveform and blood pressure in a completely non-invasive fashion, a simple touch of a button prompts the TL-400 to continuously display a patient’s advanced hemodynamic parameters including but not limited to cardiac output (CCO), cardiac power (CPO), systemic vascular resistance (SVR), stroke volume variation (SVV), and pulse pressure variation (PPV). The TL-400 provides physicians with a stream of real-time advanced hemodynamic data that was only previously available using either highly invasive (pulmonary artery catheter and femoral artery thermodilution) devices or less invasive (radial artery pulse contour analysis) technologies. The sister TL-300, already cleared in the US and Chinese markets, displays a patient’s beat-to-beat arterial waveform and blood pressure, avoiding the blind-time associated with a deflated or inaccurate cuff. Both the TL-400 and TL-300 can enhance overall hemodynamic monitoring, which has been definitively linked to improved clinical outcomes.
Both devices have a sleek, touch-screen user interface and the operator is readily able to view trend data for up to a 12-hour period. In addition, the TL-400 offers the innovative Hemopath™ view which displays a one-view-see-all on a single screen, providing the physician an easy to understand, yet comprehensive hemodynamic snapshot of the patient. The screen displays data coming from an integrated bracelet, sensor, and wrist frame placed over the patient’s radial artery. The wrist frame is disposed at the end of the case and the bracelet and sensor are immediately available for the next patient. Today, the T-line family is used in a number of clinical environments including the operating room, intensive care unit (ICU), and electrophysiology lab.
“The TL-400 and TL-300 represent significant advances in non-invasive, hemodynamic monitoring tools,” commented Dr. Jamie Sulley, Tensys’ Chief Operating Officer. “Measuring advanced hemodynamic parameters in a completely non-invasive fashion opens new avenues in critical care as these platforms display vital patient data with almost zero patient risk,” added Dr. Sulley.
About Tensys
Tensys Medical, Inc. is a leader in the development and commercialization of continuous, non-invasive, hemodynamic monitoring systems. Without a single needle stick, the company’s FDA approved and CE-Marked T-line technology is used today in hospital operating rooms, ICUs and electrophysiology labs to provide a patient’s real-time pulse pressure waveform and blood pressure. With the future addition of advanced hemodynamic parameters, Tensys is positioned to continue its leadership in the growing, non-invasive, hemodynamic marketplace.
Cautionary Statement Regarding Forward-Looking Statements
This press release may include “forward-looking statements” intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by phrases such as “will,” “near future,” “positioned,” “provide,” or other words or phrases of similar import that are intended to identify forward-looking statements. Similarly, statements herein that describe Tensys Medical’s business strategy, outlook, objectives, plans, intentions, or goals also are forward-looking statements. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements, including: the clinical and commercial potential and success of the company’s TL-300 product and T-Line product line; general economic and business conditions; and other risks and important factors that could cause actual results to differ materially from the forward-looking statements. The forward-looking statements included in this press release are made only as of the date of this announcement, and Tensys Medical undertakes no obligation to update the forward-looking statements to reflect subsequent events or circumstances after the date on which they were made.
Contact:
Tensys Medical Inc.
A. Prof. Dr.med. Oliver Gödje, MD, PhD, FCCP
Medical Director
Phone: +1-858-552-1941
US-Mobile: +1-858-204-5728
DE-Mobile: +49-172-7555566
ogoedje@tensysmedical.com
www.tensysmedical.com
or
Dr. Eric Daniels, MD, MBA
Vice President, Marketing & Sales
Phone: +1-858-552-1941
Mobile: +1-858-243-6567
edaniels@tensysmedical.com
www.tensysmedical.com
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