ProCell® Receives CE Marked Approval for Selling Into the European Union
BOSTON, February 9, 2024 (Newswire.com) - ProCell® Surgical Inc. has successfully been registered and is certified to be compliant to the requirements of ISO 13485:2016 under the MDSAP scope. Additionally, ProCell® has received CE marked approval for its Sponge Blood Recovery Unit which has been found in conformity with Regulation (EU) 2017/745 for Medical Devices.
The company’s unique patented design effectively replaces the manual and outdated activity of hand-wringing for surgical sponge-blood recovery with intraoperative autotransfusion (IAT). ProCell® will augment an institution's existing IAT device and put hospitals at the forefront among institutions, providing an exceptional new standard of patient care, which is also more cost-effective.
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. 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® is an important tool in any patient blood management/blood conservation armamentarium and has the potential to help in the overall effort, especially when sponge blood accounts for 30% to 50% of total blood loss during surgery. With ProCell® all efforts should be made to optimize that recovery.
Marc Pelletier (MD, MSc, FRCSC), the Chief of Cardiac Surgery at University Hospitals Cleveland Medical Center, describes his surgery team’s experience with ProCell®, "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.”
Pelletier continues, “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 from this type of innovative surgical product.”
“ProCell® Surgical’s sponge blood recovery system brings the first automated innovation for sponge blood recovery directly to the operating room table,” stated Robert Krensky, MD, President and co-inventor of the device. “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.”
Mike Kehoe, CEO of ProCell®, states, “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.”
More about ProCell®:
ProCell® is a medical device company dedicated to elevating the standard of care through developing and manufacturing proprietary medical devices. Headquartered in Canton, Massachusetts.
For more information, please contact: email@example.com.
Source: ProCell Surgical US, Inc.