Newswise — NEW YORK, NY– November 30, 2016—The Mount Sinai Health System (MSHS) announced the launch of the DigniCap® scalp cooling system, which was recently cleared by the U.S. Food and Drug Administration (FDA) to reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, in three of its cancer center locations. Mount Sinai is also the first and only health system in New York to currently offer breast cancer patients the Dignicap, which is now available at the Dubin Breast Center of The Tisch Cancer Institute, Mount Sinai Downtown-Chelsea, and Mount Sinai West. In the FDA clinical trials completed in the United States, 7 out of 10 patients with early-stage breast cancer kept at least 50 percent of their hair.
“We are extremely excited to be able to offer patients the Dignicap scalp cooling system during chemotherapy, which allows them to retain normalcy and privacy in their lives,” said Paula Klein, MD, Associate Professor of Oncology and Hematology at the Icahn School of Medicine at Mount Sinai, who studied the Dignicap system as part of a multi-center clinical trial which eventually led to FDA clearance in December 2015. “Losing hair is one of the more distressing side effects of chemotherapy, and this is a game changer for so many patients.”
The DigniCap scalp cooling system, made by the Swedish company Dignitana AB, with U.S. headquarters in Dallas, Texas, features a patented tight-fitting silicone cooling cap that is placed directly on the head and an outer neoprene cap that insulates and secures the silicone cap. The cooling cap is connected to a cooling and control unit with touch-screen prompts. A liquid coolant circulates throughout the silicone cap, delivering consistent and controlled cooling to all areas of the scalp. The cap is fitted to the head, and the temperature of the scalp is lowered, resulting in vasoconstriction with reduced delivery of chemotherapy to the scalp, as well as reduced cellular uptake of drugs due to decreased intrafollicular metabolic rate. These factors together reduce the risk of chemotherapy-induced hair loss.
“Time and time again, I have heard so many of my female patients with breast cancer tell me that hair loss was the worst part of their chemotherapy,” said Charles Shapiro, MD, Director of Translational Breast Cancer and Research, and Director of Cancer Survivorship at The Tisch Cancer Institute. “But now there is a treatment to mitigate this side effect and help to improve a patient’s experience during a very difficult time in their life.”
"Mount Sinai was an important partner for Dignitana as we clinically tested the DigniCap system to ensure safety and efficacy," said Bill Cronin, CEO of Dignitana, Inc. "To be able now to offer women throughout the entire Mount Sinai system an alternative to chemotherapy-induced hair loss is a major step forward in our vision to make what for many is an emotionally traumatic side effect, a thing of the past."
About the Mount Sinai Health System
The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community-based facilities to tertiary and quaternary care.
The System includes approximately 7,100 primary and specialty care physicians; 12 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is on the “Honor Roll” of best hospitals in America, ranked No. 15 nationally in the 2016-2017 “Best Hospitals” issue of U.S. News & World Report. The Mount Sinai Hospital is also ranked as one of the nation’s top 20 hospitals in Geriatrics, Gastroenterology/GI Surgery, Cardiology/Heart Surgery, Diabetes/Endocrinology, Nephrology, Neurology/Neurosurgery, and Ear, Nose & Throat, and is in the top 50 in four other specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 10 nationally for Ophthalmology, while Mount Sinai Beth Israel, Mount Sinai St. Luke's, and Mount Sinai West are ranked regionally. Mount Sinai’s Kravis Children’s Hospital is ranked in seven out of ten pediatric specialties by U.S. News & World Report in "Best Children's Hospitals."
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