Haemonetics Corporation has received US regulatory clearance for a proprietary plasma collection bowl that removes white blood cells ("leukoreduction") from plasma without requiring an attached filtration device, according to a release. The new Haemonetics system is already in use in Europe.

Intended for use as part of Haemonetics' PCS 2 plasma collection system, the High Separation ("HS") Core bowl represents a significant improvement in plasma quality and ease of collection. The bowl will be the first Haemonetics system to provide filter-free, leukoreduced plasma that meets or exceeds worldwide quality standards while maintaining the full therapeutic benefit of the plasma-derived products, including pharmaceuticals such as Intravenous Immunoglobulin and Factor VIII.

An important advantage of Haemonetics centrifuge-based plasma separation technology is its ability to process the donor's plasma without activating its complement, coagulation, or fibrinolytic systems. One risk of activation is a reduction in critical plasma proteins, plasma yield, and the effectiveness of the drugs manufactured from the plasma, the release says.

Haemonetics' new HS Core bowl will provide the benefit of automated leukoreduction. The leukocyte levels in plasma collected with the HS Core bowl meet or exceed guidelines issued by FDA for a claim of a leukoreduced blood product.

Brad Nutter, Haemonetics president and CEO, said, "The plasma collection industry is moving toward leukoreduced plasma for supply to its fractionation customers. We are pleased that we can support this industry trend with a product that can be easily integrated into customers' operations as the system requires no additional disposable parts or processing steps."

More than 750,000 plasma collection procedures have already been performed successfully with the HS bowl since its 2002 European introduction.

The HS Core bowl is incorporated into a single use, disposable plasma collection set for the PCS2 system. It has a patented secondary separation chamber that provides additional centrifugal separation to remove white blood cells from plasma. A reflective plate on the shoulder of the HS Core bowl allows optical sensors on the PCS2 to detect the end of a collection cycle earlier than in previous bowl versions, providing improved cellular separation.

Haemonetics is a global company engaged in the design, manufacture and worldwide marketing of automated blood processing systems.