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FDA Clears Next-Generation Scalp-Cooling Device


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ON JUNE 27, 2019, the U.S. Food and Drug Administration (FDA) granted clearance of the DigniCap Delta scalp-cooling system to Dignitana, for use by health-care providers in the United States. The device is a fourth generation of the DigniCap scalp-cooling system. It is indicated to reduce the frequency and severity of hair loss during chemotherapy in patients with solid tumor cancers who may receive alopecia-inducing chemotherapeutic agents as part of their therapy.

The device is a computer-controlled system and is used during treatment. The patient wears a head cap that circulates liquid to cool the patient’s scalp during chemotherapy treatment.

The cooling is intended to constrict blood vessels in the scalp, which reduces the amount of chemotherapy that reaches cells in the hair follicles. The cold temperature also decreases the activity of the hair follicles and slows down cell division, making them less affected by chemotherapy. The combined actions are thought to reduce the effect chemotherapy has on the cells, which may reduce hair loss. The cap may not work with some chemotherapy regimens.

The new “Delta” device is an advanced and redesigned model of the 2015 DigniCap system with precise temperature control. Improvements over the earlier model include: single patient use—the new cap system provides each patient with a flexible cooling wrap and an adjustable thermal cap designed to optimize scalp-cooling outcomes and minimize clinic storage needs; smaller size; and reduced nursing time required.


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