News | September 04, 2007

FDA Approves Human Thrombin to Stop Bleeding in Surgery

September 5, 2007 - The FDA has approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery.
Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases.
Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal.
“The approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research. “Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma.”
In a clinical trial involving several hundred subjects, Evithrom was found comparable to cattle-derived thrombin in both safety and effectiveness.
Evithrom is manufactured by Omrix Biopharmaceuticals Ltd., Ramat Gan, Israel, and will be distributed by Johnson & Johnson Wound Management, a division of Ethicon Inc. of Somerville, NJ.

For more information: www.fda.gov

Related Content

Transpara Deep Learning Software Matches Experienced Radiologists in Mammogram Reading
News | Computer-Aided Detection Software | January 12, 2018
Deep learning and artificial intelligence improves the efficiency and accuracy of reading mammograms, according to...
Women Prefer Getting Mammograms Every Year
News | Mammography | January 09, 2018
Women prefer to get their mammograms every year, instead of every two years, according to a new study presented at the...
Planmed Clarity 2-D Digital Mammography System Receives FDA Approval
Technology | Mammography | January 08, 2018
The U.S. Food and Drug Administration (FDA) issued an approval letter for the Planmed Clarity 2-D full-field digital...
Overweight Women May Need More Frequent Mammograms
News | Mammography | January 04, 2018
Women with higher body mass index (BMI) face an increased risk of not detecting their breast tumor until it has become...
About 25 percent of screening patients and 60 percent of diagnostic patients do not have prior mammograms available for comparison at the time of their examinations due to the lack of interoperability or other restrictions preventing clinicians from accessing prior exams.

About 25 percent of screening patients and 60 percent of diagnostic patients do not have prior mammograms available for comparison at the time of their examinations due to the lack of interoperability or other restrictions preventing clinicians from accessing prior exams.

Feature | Breast Imaging | January 02, 2018 | Kathryn Pearson Peyton, M.D.
Sixty million women undergo regular screening mammography in the United States, but even in the digital age, it is di
Double Black Announces Gemini Series Monitors for Multimodality and Digital Breast Imaging
Technology | Flat Panel Displays | December 28, 2017
December 28, 2017 — Double Black Imaging and their Image Systems Division are releasing their Gemini Series 6MP and 8
iCAD's PowerLook Tomo Detection Experiences Growing Adoption
News | Mammography | December 14, 2017
December 14, 2017 — iCAD Inc.
Siemens Healthineers Introduces Mammomat Revelation Mammography System for Improved Biopsy Workflow
Technology | Mammography | December 11, 2017
Siemens Healthineers unveiled the new Mammomat Revelation premium mammography platform at the 2017 Radiological Society...
Breast Cancer Screening Performance Impacted by Mean Mammographic Compression Pressure
News | Mammography | December 08, 2017
Dutch researchers demonstrated a strong relationship between compression pressure in mammography and breast cancer...
Videos | Mammography | December 06, 2017
Martin Yaffe, Ph.D., FAAPM, senior scientist, physical sciences/imaging research, Sunnybrook Health Sciences Centre,
Overlay Init