Endometriosis Cryoablation With ProSense System Reports Efficacy Rate of 92.8% to Avoid Secondary Surgery

In a single-site study, the ProSense System from IceCure Medical Ltd, a minimally-invasive cryoablation technology, was reported to significantly reduce pain and obtain local control of extraperitoneal endometriosis (EE), resulting in an efficacy rate of cryoablation to avoid secondary surgery of 92.8% per patient and 93.6% per nodule treated. The study also reported median pain-free survival rates were 93.75% at 6 months and 82.72% after 12 months, 24 months, and 36 months.Pain decreased from a median of 8/10 on the visual analogue scale to 0/10 at the last follow-up (P < 0.0001). Four patients had an adverse event in the days following the procedure, and one patient had a severe adverse event.

The study was conducted at the Sorbonne University Department of Interventional Radiology and Oncology, Tenon Hospital in Paris, France by lead investigator Francois H. Cornelis, MD, PhD.

Cryoprobes used in the study were of two types: IceCure's ProSense cryoprobe and Varian's V-probe. The purpose of the study was to retrospectively evaluate the pain-free survival of percutaneous (minimally invasive, through the skin) image-guided cryoablation of symptomatic EE. 42 patients with a total of 47 lesions were treated. Patients were made aware that cryoablation was offered as a minimally invasive alternative to surgery, and that a surgical procedure may be performed if cryoablation failed. According to the published study, the therapeutic options thus far to avoid the progression of endometriosis and reduce symptoms have been limited to hormonal agents and wide surgical excision. During the last decades, minimally invasive techniques such as cryoablation have been suggested as a promising option to treat abdominal wall endometriosis with satisfactory outcomes and low morbidity.

"We are grateful to Dr. Cornelis and the team of doctors at Sorbonne University and Tenon Hospital, where the data was collected, for having used our ProSense system, in addition to those from another company, as part of this independent study. Tenon Hospital institution is highly regarded in the field of gynecology and interventional radiology. We believe that the independent study has demonstrated the value of cryoablation in treating endometriosis, a chronic and painful condition in dire need of an effective minimally invasive treatment," stated Eyal Shamir, IceCure's Chief Executive Officer. "The ProSense system has regulatory approval in several countries, including FDA clearance for use as a cryosurgical tool in gynecology, and we are pleased that doctors now have more evidence of cryoablation's efficacy in patients with extraperitoneal endometriosis."