FDA expands indication for DigniCap chemotherapy device

The FDA today cleared the expanded use of Dignitana‘s DigniCap Cooling System as a tool to reduce hair loss during chemotherapy. This marks the 1st time the U.S. regulatory agency has cleared a cooling cap for use in cancer patients with solid tumors, according to the FDA.

Hair loss is common in patients taking certain types of chemotherapy, especially if they’re being treated for solid tumor cancers.

“We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,” Dr. Binita Ashar, the director of the FDA’s division of surgical devices, said in prepared remarks. “Managing the side effects of chemotherapy is a critical component to overall health and quality of life.”

The DigniCap device includes a cap that is worn on the patient’s head, circulating liquid to cool the scalp during chemotherapy. The device is controlled from a computer and is held in place with a 2nd cap that also insulates the device, keeping it cold.

The cap is designed to constrict blood vessels in a patient’s scalp, thus reducing the dose of chemotherapy that gets to the cells within the hair follicles. The cold temperatures also slow the activity of hair follicles.

The DigniCap won FDA clearance in 2015 for the use in patients with breast cancer.

The device is contraindicated for pediatric patients and patients with certain cancers or those who are taking specific chemotherapy regimens.

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