Anastomotic (point of surgical connection) leakage after a colorectal resection is associated with significant mortality and morbidity. In general anastomotic leakage occurs in as many as 15% of all colorectal resections. Low anterior colorectal resections have a higher probability for anastomotic leakage that can reach up to 19%. Thus, there is a clear and unmet surgical need for a sealant that provides a protective layer that can save a patient’s life as well as help improve a patient’s recovery and quality of life by reducing leakage, associated complications and the need for repeat operations.
The LifeSeal™ Surgical Sealant, LifeBond’s first product, is a CE marked product specifically designed to answer this unmet need by providing life-saving staple-line reinforcement in gastrointestinal procedures, including low anterior resection (LAR) anastomoses. By forming a robust reinforcement layer on a soft tissue site, LifeSeal™ aims to minimize post-operative complications such as staple-line leakage. As with all of LifeBond’s products, LifeSeal™ is a proprietary, gelatin-based medical device based on biocompatible components of natural origin. LifeSeal Surgical Sealant is a unique biosurgical medical device and is free from the limitations associated with products which rely on blood derivatives or synthetic components.
LifeSeal™ Surgical Sealant is a medical device intended for application in both open and laparoscopic procedures. It uses a special ergonomic applicator that is designed to easily and efficiently apply the sealant to tissues, including in very low, hard-to-reach locations. The two components are combined inside the applicator in real-time and then applied in a gel form to the staple-lines. Once applied, LifeSeal™ transforms into a durable, elastic and transparent protective layer that is designed to conform well to tissue and imitate its natural properties. The implant is intended to help reinforce the staple lines and minimize leakage. LifeSeal™’s adhesive properties are intended to enable it to remain in place long enough to create an environment that supports the body’s natural healing and tissue repair processes, before it naturally degrades.
LifeSeal™ Surgical Sealant was evaluated in a multi-national, randomized-controlled clinical study in which the sealant was applied in high-risk low anterior resection (LAR) anastomosis procedures. Study results confirmed LifeSeal™’s safety and demonstrated a trend in anastomotic leak reduction as more than twice as often leaks were reported in patients with standard treatment compared to LifeSeal™ treated patients (8 vs. 3 leaks in 70 patients). LifeSeal™ is the first surgical sealant CE Marked in Europe for application in the entire gastro-intestinal tract to provide reinforcement and help reduce leaks. Initial product commercialization in 2016 will take place in Europe.
*LifeSeal™ is CE marked and available for commercial use in Europe. LifeSeal™ is limited by U.S. law to investigational use only and is not yet approved for sale or distribution in the US