A Medical Device Daily

StemCor Systems (Menlo Park, California), a device company developing systems for regenerative medicine, reported receiving 510(k) clearance for its MarrowMiner system used to harvest bone marrow harvesting.

The MarrowMiner system offers a minimally-invasive procedure in the outpatient setting, without general anesthesia. The system consists of an access guide, a powered handle that drives a flexible atraumatic shaft through which marrow is aspirated, and an integrated marrow collection container. The MarrowMiner shaft gains access to the bone marrow cavity through the access guide to allow the removal of bone marrow through a single entry site.

The MarrowMiner procedure contrasts with the current practice of bone marrow aspiration through the insertion of a needle into multiple sites in the iliac crest of the hip, usually requiring general anesthesia, an operating room and multiple clinical personnel. Preclinical studies demonstrated the ability of the MarrowMiner to safely harvest large volumes of marrow with significantly higher stem cell activity than in standard needle aspirates.