International Biophysics obtains FDA 510k clearance for the FloPump® 32 centrifugal heart pump
AUSTIN, Texas, Jan. 17, 2018 — International Biophysics Corporation, a global medical device manufacturer based in Austin, Texas, announced they have received FDA 510k clearance for their FloPump 32 centrifugal disposable heart pump. The FloPump 32 is one of the smallest centrifugal pumps in the world at 32ml prime. The FloPump 32 is a single use, centrifugal heart pump designed and intended to be used in conjunction with the Maquet® RotaFlow™ console.
International Biophysics founder and CEO, H. 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.
Added Mr. Shockley, "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 Biomedical Inc. of Austin, Texas will be the sole distributor of the FloPump 32 in the United States. Origen Biomedical manufactures and sells specialized medical devices including pediatric cardiac catheters. After an estimated early 2018 clearance in Canada, Origen will also distribute the FloPump 32 on the Canadian market.
Origen's founder and CEO, Richard Martin said, "We are very pleased with the FDA declaration of substantial equivalence on the FloPump 32. We believe that the release of this device in the United States will give wider availability and more options to institutions using Rotaflow™ hardware."
International Biophysics brings to market innovative, disruptive medical devices and technologies that improve treatment therapies and patient outcomes. Centered on a precision ISO 13485 certified, FDA registered quality controlled manufacturing facility in Austin, Texas, International Biophysics has a 25 year pedigree of successful medical product and technology launches around the globe.