Channel Medsystems said today it won CE Mark approval in the European Union for its Cerene cryotherapy endometrial ablation device designed for treating women with heavy menstrual bleeding due to benign causes.
The Emeryville, Calif.-based company said that current endometrial ablation procedures can be painful and require general anesthesia, but its Cerene device and associated procedure are comfortable and usable in an office setting with no post-procedure downtime.
“Finding the right treatment can be a challenge for women. The introduction of the Cerene procedure in Europe will allow gynecologists to provide a new treatment option to their patients, one that may become more routine because it is designed to be more comfortable than traditional endometrial ablations, even without IV sedation or general anesthesia,” Dr. Mark Emanuel of Utrecth, Netherland’s University Medical Center said in a prepared statement.
“From inception, our team has worked to understand what women and gynecologists are seeking in a new treatment for heavy menstrual bleeding. We’ve integrated that feedback into our development process and are excited that women in Europe will now have access to a treatment that is intended to meet their unique needs,” CEO & prez Ric Cote said in a press release.
Channel Medsystems said it has completed the treatment phase of a 242-woman pivotal study in the US as it collects data necessary for FDA approval. Last November, Channel Medsystmes said it won FDA investigational device exemption trial approval to run a pivotal trial of its Cerene device.