SBIR Phase II: Development of a Barrier Film to Prevent Post-operative Internal Scarring

Sintact Medical Systems, Llc, Bloomington IN

Investigators

Abstract

This Small Business Innovation Research (SBIR) Phase II Project will continue development of a non-resorbable surgical film which prevents internal tissue-attachment. The proposed device will improve post-surgical outcomes from patients who suffer from internal tissue-attachment triggered by cardiothoracic or neurological surgery. Patients who undergo surgery are at risk for developing unwanted tissue-attachment due to trauma as a result of surgical intervention. This tissue-attachment can lead to severe complications and increase the burden of post-operative care resulting additional expenditures through extended hospital stays, readmissions, and increased morbidity and mortality rates. In addition, undesirable tissue attachment can obstruct the surgical field upon re-operation when necessary. Surgical related tissue-attachment is a problem amongst many surgical procedures in a number of areas. However, cardiothoracic and neurological procedures are often more complicated than gastrointestinal or gynecologic procedures, making any complications more expensive and risky to providers, payers and patients. Additionally, re-operations in cardiac or neuro-spine cases are extremely difficult, which underscore the need for an effective solutions to prevent this malady even more urgent. A product that can effectively prevent undesirable tissue-attachment and provide the surgeon with a clear surgical field and plane of view would be highly desirable in both cardio-thoracic and neurological surgery. The proposed project will conduct additional pre-clinical work leading to a regulatory submission for a cardio-thoracic indication and additional validation within the neurological field. Positive animal studies completed during Phase I & IB efforts revealed the capacity of the Sintact Film? to reduce tissue attachment and provide for a clear field of view upon re-entry or re-operation. Initial Phase II work will examine the feasibility of scaling-up certain manufacturing and production processes resulting in a clinical grade product which will undergo sterility, safety, animal, biocompatibility, and mechanical testing. This testing will be compared directly to a predicate or equivalent approved medical device. Results will need to show equivalency of the Sintact Film? to the predicate device across all testing metrics. Additional Phase II work will enable further validation of the Sintact Film? for neurological indications. A larger definitive neurological study will be completed to address the capability of the Sintact Film? to be deployed effectively in a neurological setting. Positive results from this study will provide a basis for pursuing expanded indications and additional market opportunities. If successful the implications that a non-resorbable product can be an effective countermeasure in these areas would alter the current methodology in the field.