Medical Devices

Arteriocyte gets FDA approval for solution used in stem cell device

Arteriocyte Medical Systems has received U.S. Food and Drug Administration approval for a product associated with its Magellan stem cell harvesting medical device.

The latest FDA approval for the Cleveland-based company concerns an anticoagulant solution used in the device, which harvests and quickly concentrates stem cells and blood platelets during surgeries. These concentrated cells can be injected into a patient to boost the body’s ability to repair itself.

Earlier this year, Arteriocyte received FDA approval to begin a phase 1 clinical trial investigating the device in treating compartment syndrome, a serious condition that involves a buildup of fluid pressure in soft tissue compartments within the body.

Another phase 1 trial is investigating the device in treating critical limb ischemia.

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“The synergy that the Magellan technology brings to our core efforts is a device that enables rapid bedside processing of tissue — blood or bone marrow — that delivers back to the surgeon a concentrated injectate of those cells for use as the surgeon deems appropriate,” Arteriocyte CEO Don Brown said in a 2010 interview with MedCity News.

 

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