“This installation is the culmination of extensive research and development efforts and we are eager to expand the global footprint of Dignitana with this innovative technology,” said William Cronin, CEO of Dignitana. “Gemelli University Hospital provides patients with state-of-the art care and we are honored to support their efforts with DigniCap Delta’s state-of-the-art scalp cooling.”
DigniCap Delta uses solid-state cooling for precise temperature control in an advanced and redesigned model of the 2015 FDA-cleared DigniCap Scalp Cooling System. The new DigniCap Delta device delivers significant improvements over other scalp cooling systems on the market. It features a new single patient use cap system consisting of a flexible Cooling Wrap and an adjustable Thermal Cap to optimize scalp cooling outcomes and ease-of-use for patients and nurses. The streamlined DigniCap Delta is 54 percent smaller than the previous DigniCap model and the intuitive interface provides up to 80 percent reduction in nursing time per patient infusion versus the existing device.
“We are honored to be the first in the world to receive DigniCap Delta, the very latest in scalp cooling technology. This treatment makes a huge difference in quality of life, and it is important for us to provide our patients with the very best scalp cooling system available,” said Dr. Riccardo Masetti, President of Komen Italia and Director of the Integrated Breast Center of the Agostino Gemelli IRCS University Hospital Foundation.
Fondazione Policlinico Universitario A. Gemelli is the largest hospital in Rome and one of the largest private hospitals in Europe. The hospital treats over 1,000 new patients newly diagnosed with breast cancer per year and administers more than 40,000 chemotherapy treatments annually. The Gemelli Day Hospital began offering DigniCap to patients in 2015.
Plans for additional installations of DigniCap Delta in Europe are underway. FDA clearance is anticipated for late summer 2019, after which the device will be available in the United States.
Hailed internationally as a life-changing medical advancement for cancer patients, The DigniCap Scalp Cooling System was invented in 1999 by a Swedish Oncology nurse and has been available in Europe since 2001. DigniCap was the first scalp cooling system to be cleared by the FDA in 2015 for use by breast cancer patients and the first to receive FDA clearance for use by patients with solid tumor cancers in July 2017. Data from clinical studies around the world, including the pivotal trial for FDA clearance, have illustrated that DigniCap provides clinically superior scalp cooling.