D-Stat® Rad-Band topical hemostat
|D-Stat Rad-Band Brochure
D-Stat Rad-Band IFU US
D-Stat Rad-Band Clinical Deployment Steps
The D-Stat Rad-Band is contraindicated in persons with known sensitivity to bovine-derived materials.
Please see the product Instructions for Use (IFU) for a complete listing of the indications, contraindications, warnings and precautions for this product.
CAUTION: Federal Law (U.S.) restricts this device to sale by or on the order of a physician.
D-Stat is a registered trademark of Vascular Solutions, Inc.
|The use of topical bovine thrombin preparations has occasionally been associated with abnormalities in hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which rarely have been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and/or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency. Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and/or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.|