Medical devices manufacturer International Biophysics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its FloPump 32 centrifugal disposable heart pump.
Claimed to be one of the smallest centrifugal pumps in the world, the FloPump 32 is a single use and disposable centrifugal heart pump that can be used along with the Maquet RotaFlow console.
Texas-based Origen Biomedical will exclusively distribute the FloPump 32 centrifugal disposable heart pump in the US.
Origen Biomedical produces and markets specialized medical devices such as pediatric cardiac catheters.
Once secured approval in Canada, Origen will also serve as distributor for the FloPump 32 in the Canadian market.
International Biophysics founder and CEO David Shockley said: "With this FDA clearance of our FloPump 32 for the U.S. market we continue to bring the highest quality surgical products to the market while lowering healthcare costs.
"We launched the FloPump 32 internationally to strong demand in 2017 when we received both the CE mark for Europe and ANVISA for the Brazilian market. We anticipate the same strong demand here in the U.S now that we have been cleared for this market too."
Origen founder and CEO Richard Martin said: “We believe that the release of this device in the United States will give wider availability and more options to institutions using Rotaflow hardware."
With a manufacturing facility in Austin of Texas, International Biophysics develops and produces cardiovascular heart pumps, bio sensors, surgical instruments, medical laser systems and portable oxygen concentrators.
Image: The FloPump 32 centrifugal disposable heart pump. Photo: courtesy of PRNewsFoto / International Biophysics Corporation.