Technology | January 03, 2013

Tensys Receives FDA Clearance for New Continuous, Noninvasive Hemodynamic Monitoring System

Tensys Medical Systems Inc. TL-300 Hemodynamic Monitoring System

January 3, 2013 — Tensys Medical Inc has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the TL-300, the company’s latest generation hemodynamic monitoring system. The TL-300 is a member of Tensys’ established T-Line family, which has successfully been used by over 50,000 patients since commercial launch. The T-Line technology accurately and continuously captures a patient’s beat-to-beat waveform and blood pressure in a completely noninvasive fashion, providing physicians with a stream of real-time hemodynamic data that is not possible using traditional noninvasive blood pressure (cuff) devices. Avoiding the blind-time associated with a deflated or inaccurate cuff can enhance hemodynamic monitoring, which has been definitively linked to improved clinical outcomes.

The TL-300 features a tablet-supported monitor that allows touch screen control and displays a patient’s key hemodynamic parameters. In addition to continuous beat-to-beat blood pressure and arterial waveform, the operator is readily able to view trend data for up to a 12-hour period. The tablet 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-300 represents our continued commitment to delivering next generation, non-invasive, hemodynamic monitoring tools,” commented Oliver Goedje, Tensys’ medical director. “This new system will not only enhance our current product offering, but will serve as a platform as we add cardiac output and additional hemodynamic parameters in the near future.”

Tensys will be providing additional details regarding the TL-300 launch and other company initiatives at the upcoming 2013 OneMedForum in San Francisco, Calif. Tensys management will be presenting on Jan. 9 at 10:10AM (presentation room Franciscan).

For more information: www.tensysmedical.com

Related Content

News | Cath Lab | February 23, 2018
February 23, 2018 — CorFlow Therapeutics AG announced that the company will present new insights into the coronary mi
Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab | November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab | November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Overlay Init