The Sponge Blood Recovery Unit eases the extraction of blood from surgical sponges as a preliminary step during the IAT process
ProCell Surgical gets commercialisation approval for blood recovery device in EU. (Credit: Newswire/ProCell Surgical US, Inc.)
US-based medical device company ProCell Surgical has secured CE marked approval for its Sponge Blood Recovery Unit for commercialisation in the European Union (EU).
ProCell Surgical’s proprietary device is a patient blood management product for intraoperative autotransfusion (IAT). It is said to be an easy-to-use, compact, sterile, and disposable device powered by standard operating room (OR) vacuum suction.
Its Sponge Blood Recovery Unit eases the extraction of blood from surgical sponges as a preliminary step during the IAT process.
This device was found in compliance with Regulation (EU) 2017/745 for Medical Devices.
Additionally, ProCell Surgical has successfully registered itself and is now certified to be compliant with the requirements of ISO 13485:2016 under the Medical Device Single Audit Program (MDSAP) scope.
ProCell Surgical CEO Mike Kehoe said: “In my 30-plus years of managing medical device companies, this is the only product that I have been involved with that is not only cost-effective and proprietary but represents a generational paradigm shift in the approach to conservation of blood during surgery.
“Obtaining the CE mark for marketing our unique sponge blood recovery device throughout Europe broadens ProCell’s geographic reach to provide safe and cost-effective solutions globally.”
The company’s patented design of the blood recovery unit is said to change the manual and old process of hand-wringing for surgical sponge-blood recovery with IAT.
According to the medical device firm, its blood recovery unit will boost an organisation’s current IAT device. It will also position hospitals at the forefront of healthcare facilities by offering a new and economical quality of patient care.
ProCell Surgical co-inventor Robert Krensky said: “ProCell Surgical’s sponge blood recovery system brings the first automated innovation for sponge blood recovery directly to the operating room table.
“It is easy to operate and can be used repeatedly during its single-case use. ProCell essentially closes the technology gap that existed during this important preliminary phase of IAT.”