Le Lézard
Classified in: Health
Subjects: PDT, WOM, FDA

Channel Medsystems® Receives U.S. FDA Approval of the Cerene® Cryotherapy Device for the Treatment of Heavy Menstrual Bleeding


EMERYVILLE, Calif., April 2, 2019 /PRNewswire/ -- Channel Medsystems®, a company dedicated to bringing innovation to the delivery of women's healthcare, today announced that the U.S. Food and Drug Administration (FDA) has approved the Cerene® Cryotherapy Device as a new approach to treating heavy menstrual bleeding. 

Channel Medsystems. (PRNewsFoto/Channel Medsystems)

The Cerene Device delivers cryotherapy to freeze the lining of the uterus in order to significantly reduce future menstrual bleeding. The unique design of the Cerene Device and use of extreme cold results in a procedure that does not require general anesthesia and can be performed in the gynecologist's office. In contrast, heat-based endometrial ablation devices currently on the market are more often performed with general anesthesia in hospitals or surgery centers.

CLARITY, the pivotal study supporting the safety and effectiveness of the Cerene Device and its FDA approval, included treatment of 242 subjects.  At 12 months, the observed reduction in menstrual bleeding exceeded treatment goals. "We are extremely pleased by the results of the CLARITY study and the positive feedback we have received about the Cerene Device, both from study investigators and numerous gynecologists surveyed," said Ric Cote, President and Chief Executive Officer of Channel Medsystems. "The Cerene Device provides gynecologists with the first realistic option for treatment in their office, a setting that is more comfortable for women and significantly less expensive for the healthcare system.  The shift away from the operating room that the Cerene Device enables could potentially reduce the cost to treat heavy menstrual bleeding by hundreds of millions of dollars annually."

CLARITY is the first study to provide comprehensive data on both the patient experience of pain and post-ablation cavity access, two clinical findings that are highly relevant to gynecologists when selecting an endometrial ablation device. Subjects' median pain score ranged from 0 to 2 (on a 0-10 numeric scale) across eight different peri-procedural time points, with no subjects requiring general anesthesia. Hysteroscopy performed 12 months following the procedure demonstrated an accessible uterine cavity in 98.7% of 223 available subjects. CLARITY investigator Ted Anderson, M.D., Ph.D., Vice Chair of Clinical Affairs and Director of the Division of Gynecology at Vanderbilt University Medical Center, noted this was a "critical finding that allows for diagnostic evaluation including sampling of the endometrium rather than forcing hysterectomy because of unevaluable post-ablation bleeding and/or pain." 

In a Channel Medsystems survey of over 450 gynecologists, the vast majority reported that they would recommend endometrial ablation more often if perioperative pain and clinically-significant intrauterine adhesions were reduced (81% and 79%, respectively). Anderson stressed "women who suffer from heavy menstrual bleeding are seeking safe and effective treatments that are well tolerated with minimal inconvenience.  Channel Medsystems has developed a treatment that is easy to use, is reproducible in any setting of care, and is very well tolerated without anesthesia. The development of new technology like the Cerene Device could allow gynecologists to provide a safe, effective, affordable, and convenient treatment to the millions of women who seek care for heavy menstrual bleeding annually in the United States."

The Cerene Device was developed with feedback from leading clinicians and is indicated for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete. Cryoablation is a well-characterized, durable therapy routinely used to ablate malignant and benign human tissues. In the uterus, the use of cryothermic energy has been shown to reduce the likelihood of scarring and intrauterine adhesions that are often associated with the failure of heat-based ablation treatments. The team at Channel Medsystems has integrated the cryothermic energy delivery system into a disposable, self-contained, ergonomic device, eliminating the need for capital equipment.

About Channel Medsystems: 

Channel Medsystems is a privately-held company founded to bring innovation to the delivery of women's healthcare. The Company strives to develop treatments to meet the unique needs of female patients and the high standards of their healthcare providers. Channel Medsystems is committed to ensuring that women have access to high quality outcomes that can be delivered in the convenience and comfort of their healthcare provider's office. For more information, please visit www.channelmedsystems.com.

Media Contact:
Leah Polito / Hayley Fahey
Sard Verbinnen & Co.
(415) 618-8750 / (310) 201-2040

 

SOURCE Channel Medsystems


These press releases may also interest you

at 07:31
Cambridge Medical and Rehabilitation Center (CMRC), a top post-acute rehabilitation and long-term care facility in the UAE, has admitted 15 patients to its newly opened medical facility in Saudi Arabia. CMRC's new 60-bed clinic, located between...

at 05:45
Today, more than 500 individuals from across Quebec are taking part in the provincial edition of the Leucan Shaved Head Challenge, presented by Proxim. This marks the 19th edition of the Challenge, a great wave of solidarity and hope for...

at 03:05
Nanopharmaceutics promises ground-breaking innovation in the development of medicines: The Vifor Pharma Group is endowing two professorships for Nanopharmaceutical and Regulatory Science at the University of...

at 03:00
The Bay Area leader in hair loss restoration, Silicon Valley Hair Institute, is proud to announce a new informative post for persons considering hair loss surgery. The post explains how to find reviews of hair loss treatments, read reviews seriously,...

at 03:00
Andrew Spector, DMD, FAGD, FICOI, FAIDFE is a second generation dentist and a native to Bergen County, New Jersey. He has been helping patients smile for more than 28 years at his practice in Haworth, New Jersey. Gentle Dentistry, PA is a...

at 03:00
Sunshine Coast Health Centre (SCHC), considered one of the best private drug, alcohol, PTSD, and trauma treatment programs in British Columbia, Canada, is pleased to announce its sponsorship of the upcoming Canadian Mental Health Summit to be held...



News published on 2 april 2019 at 09:17 and distributed by: