Medical device company Cohera Medical has secured the Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate the clinical trial of its Sylys Surgical Sealant device.
Sylys Surgical Sealant is designed to be used in conjunction with standard closure techniques for the restoration and protection of anastomotic junctions in colorectal and ileorectal anastomosis procedures.
It is a resorbable synthetic sealant which helps in reducing anastomotic leakage by offering additional support to anastomosis during the first few days of healing, which is the period witnessing the development of leaks.
Allegheny Health Network in Pittsburgh general surgery programme director James McCormick said: “Anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality.
“We have made tremendous strides in curtailing the risk associated with intestinal anastomosis, but we are always striving for further improvement and greater patient safety.”
The prospective, multicentre, randomised clinical trial will compare patients undergoing colorectal and ileorectal anastomosis after resection with and without the sealant.
It is intended to evaluate the safety and efficacy of the sealant in minimising the leak rate involved in these procedures.
The Sylys Surgical Sealant is expected to address the unmet clinical need of the ailment facilitating an improved clinical outcome while minimising patient management costs incurred by the healthcare providers.