D-Stat Flowable
D-Stat Flowable is a thick, yet flowable hemostat designed for topical application to stop bleeding at vascular access sites following percutaneous procedures. It is also used as an adjunct treatment in sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.
In addition to being a topical hemostat, D-Stat Flowable is effective in reducing the frequency of clinically relevant hematoma formation in the prepectoral pocket of high-risk, anticoagulated patients undergoing implantation of a pulse generator.
Published data shows that, on average, the cost of treating a hematoma/hemorrhage is $6,995.* Consider the potential cost savings of using D-Stat Flowable to prevent a pocket hematoma.
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D-Stat Flowable Topical Brochure [903k]
D-Stat Flowable Pocket Protector Brochure [834k]
D-Stat Flowable IFU US [232k]
D-Stat Flowable IFU EU [648k]
The D-Stat Flowable is contraindicated in persons with known sensitivity to bovine-derived materials. Please see the appropriate product Instructions for Use (IFU) for a complete listing of the indications, contraindications, warnings and precautions for this product.
USA CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
*Reynolds et al., "The Frequency and Incremental Cost of Major Complications Among Medicare Beneficiaries Receiving Implantable Cardioverter-Defibrillators," JACC, Vol. 47, No. 12, 2006, 2493-2497.
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. |
