Adhesions are abnormal bands of scar tissue that form post-operatively in the treated area and cause organs to anomalously bind to one another. They are formed in approximately 85% of all patients undergoing routine surgical procedures and represent a major source of post-operative morbidity and mortality. The generation of adhesions following heart surgery is of special concern, since they may affect cardiac function. Furthermore, in the frequent cases where re-operations are required, adhesions obscure cardiac landmarks, making the procedure potentially life-threatening to the patient due to inadvertent vascular or cardiac injury.

This invention pertains to the development of a family of biodegradable block copolymers that combine aliphatic poly(ester) segments, which render the polymer biodegradable, and polyether chains, that impart to the material the required flexibility.

Due to the broad clinical applicability of this new family of biodegradable polymers, SyntheMed Inc., a New Jersey-based company involved in the development of novel biomedical systems, acquired from the Hebrew University the exclusive rights to these materials. Poly(ethylene oxide)/poly(lactic acid) (PELA) block copolymers of various compositions were used to prevent adhesions in both the cardiac as well the gynecological arenas in various animal models (from rabbits to large animals), with a success rate of almost 100% in both areas, as shown in the figures below. A large pivotal clinical study was conducted, where the PEO/PLA biodegradable films were implanted in just-born babies in 13 centers in the United States and 3 centers in Europe with congenital heart defects. In light of the extremely positive results of this comprehensive clinical study, the FDA approved this device for the prevention of post-surgical adhesions in the pediatric population. An additional biodegradable products was approved for the prevention of post-operative adhesions in the nasal arena.