Biom’Up, a device maker based in France, said the FDA signed off on marketing its Hemoblast Bellows hemostatic product designed to control bleeding during surgery.
The FDA nod was given seven months ahead of schedule following an inspection of Biom’Up’s manufacturing facility by the regulatory agency. Hemoblast Bellows uses patented biopolymers designed to simplify surgical procedures in numerous specialties like spine, cardiothoracic, general, orthopedic and plastic. The product doesn’t require preparation time, mixing or heating and can be used once or several times during the surgery, the company said.
The agency’s premarket approval was based on clinical trials of patients undergoing either cardiothoracic, abdominal or orthopedic (lower limb) surgery. In light of interim results of the trials—93% efficacy at six minutes, versus 74% for the control arm—the Independent Data Monitoring Committee unanimously recommended that the study be stopped prior to the initially scheduled end of this trial and that the application be submitted faster.
“We are delighted to have achieved it over half a year ahead of our initial schedule,” Etienne Binant, Biom’Up’s CEO, said in a statement. “This performance, which has set a new record in the surgical hemostasis sector for a first PMA, is the result of the extraordinary mobilization of all our teams.”
The company said it expects to begin marketing the product in the U.S. by the summer of 2018.