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  1. Device Approvals, Denials and Clearances

HEMOBLAST Bellows - P170012

HEMOBLAST Bellows - P170012

Image of the device.

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: HEMOBLAST™ Bellows
PMA Applicant: Biom'Up SA
Address: 8, Allée Irène Joliot-Curie, 69800 Saint Priest, France
Approval Date: December 15, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170012a.pdf

What is it? The HEMOBLAST™ Bellows is a handheld device used to achieve hemostasis (control bleeding) during surgical procedures. The HEMOBLAST Bellows includes a dry, sterile powder made of highly purified porcine collagen (with glucose), chondroitin sulfate, and thrombin. Users do not need to thaw, mix, or heat the powder, and the powder is absorbed by the body within four weeks.

How does it work? Surgeons use the HEMOBLAST™ Bellows to apply the hemostatic powder to the source of the bleeding by squeezing the bellows. The hemostatic powder absorbs excess blood and helps to stop bleeding. The HEMOBLAST™ Bellows Hemostatic Powder's collagen composition starts the coagulation process by absorbing blood, concentrating coagulation factors and platelets, and providing a surface for coagulation to begin.

Thrombin from pooled human plasma, as an ancillary blood derivative, is included in the powder to aid the effect of the hemostatic agent. The thrombin facilitates the conversion of fibrinogen to fibrin, which allows the blood to clot. In addition, chondroitin sulfate powder is included in the HEMOBLAST™ Bellows Hemostatic Powder formulation to provide cohesion between the hemostatic wound and the surrounding tissue.

When is it used? The HEMOBLAST™ Bellows is indicated for use in surgical procedures to help achieve hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.

What will it accomplish? During general surgical procedures, the HEMOBLAST™ Bellows achieved hemostasis within six minutes, with a significantly shorter preparation time. The effectiveness of HEMOBLAST™ Bellows and the control were measured using a validated 6-point scale for scoring the severity of bleeding within 10 minutes. The FDA found the safety profile of the HEMOBLAST Bellows to be similar to that of the control with regard to the rate and types of adverse events. There were no unanticipated adverse device effects. Common adverse events were abnormal bloodwork, anemia, arrhythmia, and pain. None of these adverse events were related to the device.

When should it not be used? HEMOBLAST Bellows should not be used in the following situations:

Do not inject HEMOBLAST™ Bellows into a vessel or tissue. There is a risk of allergic-anaphylactoid reaction and/or thromboembolic events, which may be life-threatening.

Do not apply HEMOBLAST™ Bellows in the absence of active blood flow (e.g., while the vessel is clamped or bypassed). Extensive intravascular clotting and even death may result.

Do not use the HEMOBLAST™ Bellows for treatment of severe or extreme bleeding.

Do not administer to patients with known allergies or hypersensitivity to materials of porcine or bovine origin.

Do not use in the closure of skin incisions because it may interfere with the healing of the skin edges due to mechanical interposition of the powder.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.