LASER TISSUE WELDING: BREACHING BARRIERS IN THE SURGICAL MANAGEMENT OF THE PANCREAS

Laser Tissue Welding, Inc., Humble TX

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Abstract

? DESCRIPTION (provided by applicant): The pancreas is one of the most challenging organs from a surgical perspective and there is no technology available that effectively seals this organ after resection. The development of pancreatic leakage and fistula is the single most significant cause of morbidity and mortality after pancreatectomy and abdominal sepsis occurs in 30-50% 1, 5 of the postoperative patients. Improvements in anesthesia and perioperative management decreased the surgical mortality to less than 5% for pancreatoduodenectomy,5 unfortunately, the postoperative morbidity remains high and approaches 50% even in large series. For patients undergoing distal pancreatectomy, pancreatic fistulas occurred post-operatively in 31% of patients.7 Over the long term Kazanjian et al 6 analyzed, 182 patients from 1996-2005 who underwent pancreatoduodenectomy to treat ductal adenocarcinoma, concluded that the principal factor influencing long-term survival was operative blood loss. The goal of this application is to test the first-in-human feasibility of sealing the pancreas after distal pancreatectomy using laser tissue welding (LTW). LTW is a laser-biologic combination device which uses a non-compressive, non-ablative technology to join and seal tissues instantly for controlling the leakage of blood, gastrointestinal fluids, urine, bile, lymph, and cerebrospinal fluid. It is life-saving when used on the surfaces of solid visceral organs, such as the liver spleen, pancreas and kidney, involved in trauma, cancer and transplantation in presence of coagulopathies or anticoagulation. Specific Aims 1. Partial proximal & distal pancreatectomy using laser tissue welding: Twelve week GLP preclinical safety and efficacy studies in 18 pigs (Time: 6 months) 2. Partial proximal & distal pancreatectomy using laser tissue welding: Safety and Efficacy Clinical Trial (Time: 18 months) 2.1. Investigational device exemption (IDE) submission and approval for clinical trials, and IRB approval. 2.2. Pilot human feasibility clinica study in 10 patients for distal pancreatectomy indication of use. 2.3. Pilot human feasibility clinical study in 10 patients for pancreaticojejunostomy indication of use. Potential Technology innovation: LTW has developed a combination of a process and two proprietary bioabsorbable human albumin products that are applied to seal tissues to stop fluid leaks such as blood, bile (alkaline), pancreatic (proteolytic) and urine (acidic), during surgical repair of the pancreas, lier and kidney.4, 6 This combination device has laser precision with the versatility to seal tissues without thermal ablation of normal or abnormal tissues. Anticipated Outcomes: Would require the approval of a pre-market market approval (PMA) application with separate IDE applications for each anatomical region, organ and indication of use. Potential commercial applications: LTW may be used to sealing and joining all tissues. Applications include sealing after solid visceral organ trauma and tumor resections; split liver transplants; laparoscopic nephrectomy; urethral repair, hypospadias repair, dural sealing, spinal fusion and difficult dental hemostasis.