ProCell Surgical’s Sponge Blood Recovery Unit Approved in Europe

ProCell Surgical Inc. has received CE Mark approval for its Sponge Blood Recovery Unit, which conforms with Europe’s new Medical Device Regulation.

“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,” ProCell Surgical CEO Mike Kehoe said. “Obtaining the CE mark for marketing our sponge blood recovery device throughout Europe broadens ProCell’s geographic reach to provide safe and cost-effective solutions globally.”
 
The company’s patented design replaces the need for manually hand-wringing surgical sponges for blood recovery with intraoperative autotransfusion (IAT). ProCell augments an institution’s existing IAT device.

“ProCell Surgical’s sponge blood recovery system brings the first automated innovation for sponge-blood recovery directly to the operating room table” ProCell Surgical President and device co-inventor Robert Krensky, M.D., stated. “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.”
 
Blood donorship has decreased significantly over the past several years, especially during the pandemic. With an automated, more efficient blood collection process, ProCell removes the risk of not using autologous blood, according to the company. IAT is used routinely in the operating room and has been shown to reduce the requirements for donor blood transfusions during surgery along with their associated risk and supply chain issues.
 
ProCell can potentially help in overall blood management, as sponge-blood accounts for 30% to 50% of total blood loss during surgery. ProCell helps clinicians optimize that recovery.
 
“It has added to our blood conservation approach, and has helped us standardize intraoperative blood salvage…in our most complex cases, it is helpful to our nursing team, helping to facilitate the use of extracting blood from multiple sponges, while minimizing distractions to our scrub nurse,” said Marc Pelletier, M.D., chief of Cardiac Surgery at University Hospitals Cleveland Medical Center. “ProCell has become a fixture in cardiac surgery at University Hospitals, and an additional tool in the surgical management of complex cardiac surgeries. Our patients only stand to benefit with this type of innovative surgical product.” 

Headquartered in Canton, Mass., ProCell develops and manufactures proprietary medical devices.