The FDA approved the nation’s first “cooling cap” intended to reduce hair loss in female breast cancer patients undergoing chemotherapy

The FDA approved the nation’s first “cooling cap” intended to reduce hair loss in female breast cancer patients undergoing chemotherapy

The DigniCap Cooling System, manufactured by Sweden-based Dignitana, is a computer-controlled device that circulates a cooled liquid while a patient is receiving chemotherapy. The cold is intended to constrict blood vessels in the scalp, in an effort to reduce the amount of toxic chemicals that can reach and harm hair roots. In addition, the cooling mechanism also reduces the activity of the hair follicles, ideally making them less susceptible to chemotherapy.

FDA based its decision on the results of clinical trials involving 122 women with Stage 1 and Stage 2 breast cancer who were undergoing chemotherapy regimens that have been associated with hair loss. Two-thirds of the patients who used the DigniCap reported losing less than half their hair, the agency said.
“We are pleased to see a product for breast cancer patients that can minimize chemotherapy-induced hair loss and contribute to the quality of life of these individuals,” William Maisel, acting director of FDA’s office of device evaluation, said in a statement. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”
Hair loss due to chemotherapy typically is temporary, but minimizing or relieving such side effects is considered a key part of overall treatment and can affect a patient’s quality of life.
Despite Tuesday’s approval, FDA made clear that DigniCap might not work with some chemotherapy regimens. It also noted such possible side effects as cold-induced headaches, neck and shoulder discomfort, chills and pain associated with wearing the cap for extended periods.
According to Dignitana’s website, the device was developed more than a decade ago by Swedish oncology nurse Yvonne Olofsson, with help from the clinic where she worked. It has been tested on patients in Germany, Japan, Russia and various European countries, the company said, and was already approved for use in Europe.
Each medical facility providing the cap will set its own price for the treatment, Dignitana explains, though it is working to have insurers help cover that cost.
“Some carriers that cover the cost of wigs have considered scalp cooling similarly and provided some reimbursement,” the company says on its site. “We believe this will become more standard practice over the next year or two.”

Sarstedt High-Speed Closed Tube Sorters

Sarstedt High-Speed Closed Tube Sorters

We are pleased to inform you that the SarstedtGroup which is being the distributor of Turkey by Özgün, has acquired the direct customer business in the field of lab automation of m-u-t GmbH.

With this acquisition, Sarstedt strengthens its wide portfolio of pre- and post-analytical solutions on the sector of laboratory automation and expands its market position as a global solution provider in this segment.

The High-Speed Closed Tube Sorters of m-u-t GmbH maintain a leading position in the field of sample accessioning in the clinical laboratory. The sorters stand out for safe, trouble-free and rapid sorting in continuous operation. Therefore, these systems optimise the work flow in sample accessioning, they complement our sample sorting segment and, on the whole, reinforce our market presence in the field of lab automation.

The transaction includes the takeover of the Turkey direct sales activities for the HCTS2000 MK2 and MK3 units by the Turkey sales organisation of Ozgun, as well as the service activities

Please contact us for your rental, after-sales services and spare parts needs.