Dignitana AB, industry leader in scalp cooling innovation, has installed the first DigniCap Delta® in the United States at the University of California, San Francisco (UCSF). The new device is the fourth generation of The DigniCap® Scalp Cooling System and received clearance from the United States Food and Drug Administration in June 2019. It is indicated to prevent chemotherapy-induced hair loss in patients with solid tumors.
“The DigniCap pivotal trial paved the way for the introduction of effective, safe and convenient FDA-cleared scalp cooling in the United States,” says William Cronin, Chief Executive Officer of Dignitana AB. ”As that clinical trial was led by UCSF, it is both an honor and a privilege to introduce the new state-of-the-art DigniCap Delta device at UCSF as well.”
“Scalp cooling offers patients the opportunity to maintain privacy and self-esteem throughout chemotherapy, enhancing overall well-being and quality of life,” says Hope S. Rugo, MD, Professor of Medicine (Hematology/Oncology) and Director, Breast Oncology and Clinical Trials Education at UCSF who led the pivotal trial. “These innovations are critically important as we work to advance cancer care and treat the whole patient as well as the disease.”
Technical advancements in the new system include solid state cooling for precise temperature control and a streamlined design that is 54 percent smaller than the previous model. A new cap system gives patients a flexible Cooling Wrap and an adjustable Thermal Cap designed to optimize scalp cooling outcomes and minimize clinic storage needs. The intuitive user interface provides up to an 80 percent reduction in nursing time per patient infusion compared to the current model.
DigniCap Delta is now available to medical centers throughout the United States with the current scalp cooling system already available in in 30 U.S. states and 37 countries around the globe.