FDA Expands Approved Use Of Cooling Cap

Dignicap FDA 120915

Nearly one and a half years after securing FDA clearance for use in breast cancer patients to reduce the severity of chemotherapy-induced hair loss, DigniCap scalp cooling system has scored yet another regulatory nod.

The FDA on Monday cleared DigniCap scalp cooling system to reduce the frequency and severity of hair loss during chemotherapy in solid tumor cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used.

Commenting on the expanded approval, Binita Ashar, director, Division of Surgical Devices, in the FDA's Center for Devices and Radiological Health, said, "We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss. Managing the side effects of chemotherapy is a critical component to overall health and quality of life."

In December 2015, the DigniCap was granted marketing authorization by the FDA for use in patients with breast cancer to reduce the severity of chemotherapy-induced hair loss. The device reportedly costs between $1500 and $3000 per patient.

Developed by Swedish medical technology company Dignitana AB. (DIGN.ST), the DigniCap features a head-worn cooling silicone cap, which is connected to a cooling & control unit from where a liquid coolant is drawn, delivering consistent and controlled cooling to all areas of the scalp. The silicone cap is covered by an outer neoprene cap that acts as an insulation cover to prevent loss of cooling.

The cooling action constricts blood vessels in the scalp which results in reduced delivery of chemotherapy to the scalp. The cold also reduces the activity of hair follicles, which slows down cell division and makes them less affected by chemotherapy.

DigniCap is contraindicated for pediatric patients, patients with certain cancers and patient undergoing specific chemotherapy treatments. Additionally, DigniCap may not be appropriate for patients with cold sensitivity or susceptibility to cold-related injuries, noted the FDA.

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