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Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) to begin a prospective, multicenter, randomized clinical trial for its Sylys® Surgical Sealant device.
Sylys® Surgical Sealant is intended to be used as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in colorectal and ileorectal anastomosis procedures.Sylys is a resorbable synthetic sealant designed to help reduce anastomotic leakage by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur.
“It is tremendous that FDA has given investigational approval to this novel device that may help reduce the incidence of anastomotic leaks and their devastating impact,” said Dr. Deborah Nagle, Chief, Colon and Rectal Surgery, Beth Israel Deaconess Medical Center in Boston, MA.
Sylys® Surgical Sealant received Expedited Access Pathway (EAP) status from the FDA in 2015, which recognizes the potential of the product to meet a serious unmet clinical need. This IDE approval represents the culmination of significant joint efforts by the company and the FDA to move forward on the clinical evaluation of this important technology.
“Anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality,” said James McCormick, DO, FACS, FASCRS, Program Director, General Surgery, Allegheny Health Network in Pittsburgh, PA.
“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 randomized clinical study will compare patients undergoing colorectal and ileorectal anastomosis after resection with and without the sealant. The study is the first phase of a clinical trial program designed to support the safety and efficacy of the sealant in reducing the leak rate in these procedures.
“We are pleased that the FDA has approved this IDE. This approval validates the Sylys® Surgical Sealant biocompatibility, pre-clinical safety profile, and clinical trial design of the study,” said Chad Coberly, JD, Chief Clinical and Legal Officer of Cohera. “The Company greatly appreciates the cooperation and high level of interaction with the FDA during the review of this potentially life-saving healthcare innovation.”
