Rotem vs TEG

Dear POC Community, 

For the sake of the conversation, there is also a third and new player in this area. Perhaps you have heard, this new POC device was granted de novo status in the US just last week

Here is a copy of the official press release from the company:

FDA grants de novo for the HemoSonics' Quantra® QPlus® System; This Revolutionary Diagnostic Provides Unique Information for Assessing Coagulation at the Point of Care; Now Commercially Available in USCharlottesville, VA - March 13, 2019 - HemoSonics today announced that its innovative Quantra Hemostasis Analyzer platform, and its initial QPlus cartridge have been granted de novo marketing authorization by the FDA and are now available for sale in the United States.

The fast and easy-to-use Quantra QPlus System provides novel and actionable information on coagulation status to clinicians at the point of care. With hands-on time of less than a minute, the Quantra QPlus System leverages innovative ultrasound technology to provide rapid viscoelastic results in 15 minutes or less, using a simple workflow and intuitive interface. When time is most critical, Quantra's rapid, precise and easy to read results may allow clinicians to quickly make more informed decisions.

"The Quantra Hemostasis Analyzer is revolutionary and a dramatic improvement over existing tools," said Dr. Danja Groves, Anesthesiologist in Charlottesville, Virginia. "Using the Quantra, clinicians have information that was previously unavailable, in a time frame that enables proactive bleeding management. This is a game-changer for transfusion management."

The Quantra QPlus System utilizes a fully sealed consumable cartridge to run a panel of viscoelastic blood coagulation tests. The Quantra's patented SEER sonorheometry ultrasound technology provides fully automated testing in a closed system, enabling point of care use in busy clinical environments. Studies have demonstrated strong correlation between the Quantra and both standard laboratory tests and other viscoelastic hemostasis assays. It also introduces unique parameters, which assess platelet contribution to clot stiffness and the likelihood of residual heparin in the sample that are only available in the US on the Quantra QPlus System.

"Critical bleeding occurs frequently in cardiac and major orthopedic surgeries," said Timothy Fischer, President and Chief Executive Officer of HemoSonics. "The Quantra QPlus System revolutionizes point-of-care management by delivering accurate and novel results in a fraction of the time required previously, near the OR, surgical suite, or ICU. Faster results can mean better management of critical bleeding, more cost-effective treatment, and ultimately better outcomes for patients."

Availability
The Quantra QPlus System is commercially available in the U.S. and Europe.

About HemoSonics
HemoSonics is a medical device company with the primary mission to deliver clinical tools that provide actionable information in the critical care setting; resulting in better care for patients and lower overall medical costs.

The Quantra Hemostasis Analyzer, the flagship product from HemoSonics, is designed to support these goals. It is designed to improve patient outcomes and reduce healthcare costs by providing unique and optimized information, for easy and fast interpretation and simple, more efficient Point of Care workflows related to bleeding management.

HemoSonics is headquartered in Charlottesville, VA, with research, development and manufacturing facilities in Durham, NC. For more information, visit www.hemosonics.com.

HemoSonics is owned by the Stago group, a leading company in the In-Vitro Diagnostics industry dedicated to the exploration of thrombosis and hemostasis.

For more information, please contact:

Lee DeGeer
VP Marketing
(919) 504-1030
Hemosonics.com

Hi Joseph,

I am in the process of validating our two new TEG 6S analyzers. As they are only approved for use with CV OR cases we will be keeping our two TEG 5000s for trauma cases.

That being said, the TEG 6S is amazing. It is built to be a POC instrument so it is very easy to use. It is not affected by outside vibrations and all reagents are included in one cartridge (well two, one citrated cartridge and one Platelet Mapping cartridge). I haven't used the TEG manager software much yet but it doesn't look like it has any features that aren't already available in the old software. The one plus I've found about TEG manager is that it is web based so you can build users for providers to view the results as they run with out having to worry about having extra licenses for them to view.

I believe that the 6S has been submitted to the FDA for approval for cases other than CV OR so stayed tuned on that.

Feel free to shoot me an email if you have more questions: ruth.harmala@mghs.org

Ruth Harmala

POC Coordinator

UP Health System-Marquette

Thanks Ruth for that insight.

We are currently collecting information on both  the TEG and ROTEM.  Has anybody have done a comparison (pros and cons) between both instruments? Would you mind sharing your rfinding with us?  You can e-mail me privately if you would like at Olivia.severdija@msmc.com

I would be interested in any pros and cons as well. You can email me at tracy.anderson@bsahs.org

Thanks in advance!

Fairly new to this role and we're looking at getting a TEG 6S or ROTEM. I would also be interested in thoughts or written comparisons of the two analyzers. My e-mail is Kathleen.hainsworth@salemhealth.org if you'd rather communicate privately.