Hamburg, Germany ; Kfar Saba, Israel. – October 2, 2024
Colospan Ltd. announced today that Hamburg based Asklepios Altona Clinic is the first Hospital in Germany to use the CG-100 intraluminal bypass device bypass device which is designed as an alternative to diverting stoma for patients undergoing colorectal surgery. The device which is CE marked in Europe under the MDR was used by Prof. Dr. med. Daniel Perez, head of General and Visceral Surgery department at Asklepios Altona Clinic as part of the pivotal study Colospan is conducting in the US, Israel and Europe.
Colorectal surgery typically includes the procedure of colorectal anastomosis where the diseased section of the colon or rectum is removed, and the two healthy segments on either side of it are reattached.
Leakage of colon content from the anastomotic site into the abdominal cavity is a dangerous complication, increasing hospitalization time, re-operation, and mortality.
To prevent leakage, surgeons often create a small opening called a stoma on the surface of the abdomen, to divert the flow of waste from the bowel into an external bag. Living with a diverting stoma can be overwhelming and uncomfortable, but a stoma is currently considered the standard treatment for almost 70% of rectal and high-risk colon resections.
“There are limited options for patients who undergo a low resection of the rectum,” said Prof. Perez. “Because the CG-100 device allows us to perform only a single minimally invasive procedure, the hope is that it can safely reduce the need for stoma and allow for a more comfortable and easy recovery, which increases the patient’s quality of life and allows them to avoid the complications that some encounter with a stoma.”
People 22-75 years old who are scheduled to undergo coloanal or colorectal surgery with stoma placement due to colorectal cancer can inquire about the study by visiting www.stomachoice.com or by calling (040) 1818 – 81 1602.
About CG-100 Intraluminal Bypass Device
Colospan’s CG-100 is intended for patients with colorectal cancer requiring an anastomosis and are to receive a protective stoma under routine clinical practice. The CG-100 Intraluminal Bypass Device is a silicone tubular sheath that is introduced into the colon using a designated delivery system. The protective sheath is held in place by a mechanism that consists of inflatable balloons and an extra-luminal ring that encircles the colon, preventing the sheath from moving downstream while protecting the anastomotic site. After approximately ten days, when the risk for anastomotic leakage is reduced and the anastomosis integrity is confirmed, the sheath and ring are removed without any surgical intervention. The CG-100 Intraluminal Bypass Devices are CE marked (under Medical Device Regulation)in the European Union (EU) and in Israel and under investigational use (IDE) in the USA.
About Colospan Ltd.
Colospan is a clinical stage medical device company that has developed a novel and proprietary solution for colorectal surgery. The company is dedicated to addressing the clinical and economic consequences of anastomotic leaks, the first and foremost challenge in colorectal surgery.
Colospan’s team consists of seasoned professionals in marketing, sales, and development of surgical devices for colorectal surgery, supported by key opinion leaders from Israel, Europe and the United States. The CG-100 is not approved for sale in the United States and is limited to investigational use.
About Asklepios
Asklepios Kliniken is one of the leading private operators of hospitals and healthcare facilities in Germany. The hospital group stands for highly qualified care for its patients with a clear commitment to medical quality, innovation and social responsibility. On the basis of this, Asklepios has developed dynamically since it was founded more than 35 years ago. The group currently has 164 healthcare facilities across Germany. These include acute hospitals at all levels of care, university hospitals, specialist clinics, psychiatric and forensic facilities, rehabilitation clinics, care homes and medical centres. In the financial year 2023, over 3.5 million patients were treated in Asklepios Group facilities. The company has more than 68,000 employees.