Abyrx, a US-based therapeutic device company, has received the US Food and Drug Administration (FDA) approval for its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use.
AHBP is a surgical ready-to-use product which achieves hemostasis by mechanical tamponade. Its formulation comprises components that are both water soluble and dispersible that can absorb within days following the surgery.
It comes in a multi-package configuration and in several sizes to accommodate hospital procurement requirements and to boost efficiency in a variety of surgical procedures across surgical specialties in which the product will be used.
AHBP complements the firm's existing surgical hemostat products which include Hemasorb and Hemasorb Apply.
Abyrx president and CEO John Pacifico said, "AHBP and other products under development complement our Hemasorb products and will provide surgeons with more options to treat their patients and help enable hospitals to reduce costs."
The surgical hemostat products are utilized by the cardiothoracic, craniomaxillofacial, spine, orthopedic, neurological, and trauma surgeons.
According to the company, more than 3.5 million patients undergoing surgical procedures each year could benefit from
the intraoperative use of its products.
Abyrx business operations vice president David Hart will be responsible for leading the market introduction of AHBP.