Research Project
6389395
Although laser assisted microvascular anastomosis (LAMA) has been demonstrated in many animal studies, this procedure has had limited clinical use. Major impediments to the acceptance of LAMA by surgeons have been concerned with safety secondary to both low acute tensile strength (of the LAMA repairs), and the subjective visual end point for tissue fusion. These two problems have been addressed via the use of biological solders to greatly increase the tensile strength of the laser welds, and the use of real time control systems for a reproducible LAMA. However, despite these advances, IDE approval for clinical use of the LAMA procedure still requires an increased efficacy compared to traditional sutured microvascular repairs. The objective of this proposal is to integrate LAMA techniques with novel tissue solders to provide in situ delivery of agents at the microvascular repair site. In the Phase II studies described here, this novel tissue repair technology will be evaluated for safety and efficacy for LAMA's use in reconstructive microsurgery. The program will also include the product development efforts necessary for FDA approval for clinical trials. PROPOSED COMMERCIAL APPLICATIONS: This research involves several novel technologies, whose combination may lead to a significant improvement in the clinical outcome for reconstructive microsurgery. The use of the resulting technology may also be applicable to the repair of larger vessels, including reconstruction of the coronary arteries, which accounts for over 500,000 procedures per year in the U.S.. Commercialization of this technology will involve a surgical system including an advanced biomedical device, and an ultrapure tissue solder.
