Laser Tissue Welding, Inc — Department of Health and Human Services SBIR Phase II: 102

Description

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 of the postoperative patients Improvements in anesthesia and perioperative management decreased the surgical mortality to less than for pancreatoduodenectomy unfortunately the postoperative morbidity remains high and approaches even in large series For patients undergoing distal pancreatectomy pancreatic fistulas occurred post operatively in of patients Over the long term Kazanjian et al analyzed patients from 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 Partial proximal andamp distal pancreatectomy using laser tissue welding Twelve week GLP preclinical safety and efficacy studies in pigs Time months Partial proximal andamp distal pancreatectomy using laser tissue welding Safety and Efficacy Clinical Trial Time months Investigational device exemption IDE submission and approval for clinical trials and IRB approval Pilot human feasibility clinica study in patients for distal pancreatectomy indication of use Pilot human feasibility clinical study in 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 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 PUBLIC HEALTH RELEVANCE The current proposal aims to address a safe and effective method of sealing pancreatic resections without complications arising from pancreatic leakage such as peritonitis sepsis and death The current state of art pancreatic surgical resections have an unacceptable pancreatic leak rate of This is because there are no FDA cleared or approved sealants or devices found to be safe or effective for sealing this organ The current standard of care is anything but standard because of the use of off label devices and sealants The key determinant of outcome after pancreatoduodenectomy Whipple procedure remains the pancreatic enteric anastomosis The development of pancreatic leakage and fistula is the single most significant cause of morbidity and mortality after pancreatectomy and abdominal sepsis in of the postoperative patients For patients undergoing distal pancreatectomy pancreatic fistulas occurred post operatively in of patients With Laser Tissue Welding technology we hope to eliminate the need for suturing stapling buttressing or ablating the pancreas significantly reduce pancreatic leakage and improve hemostasis which will improve pancreatic preservation and function Laser tissue welding LTW is an enhanced non compressive and non ablative surgical capability that can seal fluid leaks instantly and accurately including blood gastrointestinal fluids urine bile lymph and cerebrospinal fluid Relevance Laser tissue welding is a transformational technology which is quicker better and cheaper than current tissue sealants It can be ubiquitously used for almost all current surgical procedures where hemostasis is required because it seals in acid alkaline and proteolytic environments It breaks a barrier and is lifesaving when used in surgical procedures on patients suffering from clotting deficiencies or on blood thinners LTW is specifically suitable when dealing with solid visceral organs with a soft friable sponge like parenchyma such as liver pancreas spleen and kidney It enables the surgeon to undertake resections in non anatomical planes join and seal the parenchyma with minimal thermal damage This creates a new genre or paradigm of innovative enhanced surgical capabilities for several hereto unmet clinical needs in orthopedics dentistry craniofacial surgery neurosurgery urology oncology plastic and trauma surgery It is particularly well suited for minimally invasive robotic and the advent of automated surgery