NOSCAR 2010 SOLID ORGAN

Opportunity for clinical utilization Opportunity for clinical utilization Procedure Procedure Benefits and risks Benefits and risks Operator Operator Volume Volume Timeline Timeline Obstacles for adoption Obstacles for adoption Enable technology needed? Enable technology needed?

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Procedures – Organ removal Procedures – Organ removal Nephrectomy, Spleenectomy, (already published) Nephrectomy, Spleenectomy, (already published) Hepatectomy, pancreatectomy (tail), adrenalectomy… Hepatectomy, pancreatectomy (tail), adrenalectomy… Actually feasible with hybrid approach and use of rigid instruments Actually feasible with hybrid approach and use of rigid instruments Real benefits for specimen removal and optics site on natural orifice Real benefits for specimen removal and optics site on natural orifice Mainly transvaginal Mainly transvaginal Progress to real NOTES relay on tech development like Flexible staplers and platforms Progress to real NOTES relay on tech development like Flexible staplers and platforms Potential use of combined approach Potential use of combined approach

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Benefits and risks –Organ removal Benefits and risks –Organ removal Benefits Benefits Removal using natural orifices reduces abdominal wall damages of larger incisions Removal using natural orifices reduces abdominal wall damages of larger incisions Natural orifices are really near to target organs Natural orifices are really near to target organs Risks Risks Major challenges coming of bleeding from larger vessels Major challenges coming of bleeding from larger vessels

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Operator – Organ removal Operator – Organ removal Those are complex surgical procedures generally done by specialists Those are complex surgical procedures generally done by specialists Keys to development Keys to development Identify the target groups Identify the target groups Enrol them on NOTES training Enrol them on NOTES training

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Timeline – Organ removal Timeline – Organ removal Actually – Vaginal access Actually – Vaginal access Hybrid technique with rigid instruments make it feasible and seems to be safe (nephrectomy and splenectomy) Hybrid technique with rigid instruments make it feasible and seems to be safe (nephrectomy and splenectomy) Competes with single-site laparoscopy Competes with single-site laparoscopy Up to 3y Up to 3y More use of combined approach More use of combined approach Reduce the use of transabdominal rigid instrumentation Reduce the use of transabdominal rigid instrumentation New long steerable instruments ? New long steerable instruments ? Magnets? Magnets? Development of flexible stapling Development of flexible stapling Specific designed to vessel control with smaller diameter Specific designed to vessel control with smaller diameter Over 3y Over 3y Platform development will allow progression toward NOTES Platform development will allow progression toward NOTES

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Obstacles for adoption – Organ removal Obstacles for adoption – Organ removal Competes with single-site surgery Competes with single-site surgery Lack of large vessels control (flexible stapling) Lack of large vessels control (flexible stapling) Scaling (not so many procedures done) Scaling (not so many procedures done) Procedures done by “specialists” that are note involved with NOTES Procedures done by “specialists” that are note involved with NOTES

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Enable technology needed – Organ removal Enable technology needed – Organ removal Flexible stapling (vessels orientated) Flexible stapling (vessels orientated) Long steerable instruments Long steerable instruments Magnets Magnets NOTES surgical platforms NOTES surgical platforms

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Procedures -Diagnostic and non-organ removal Procedures -Diagnostic and non-organ removal Biopsy – Hepatic biopsy as killer app Biopsy – Hepatic biopsy as killer app Tumor ablation Tumor ablation Actually not on the highlight Actually not on the highlight Real benefits in competing with transabdominal approach in selected cases in-witch it can not reach the target or is ‘too risky” to do it Real benefits in competing with transabdominal approach in selected cases in-witch it can not reach the target or is ‘too risky” to do it Enables large volume caseload Enables large volume caseload Could make transgastric approach feasible and “popular” Could make transgastric approach feasible and “popular”

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Benefits and risks –Diagnostic and non-organ removal Benefits and risks –Diagnostic and non-organ removal Benefits Benefits Potential use for sedation / endoscopic suites Potential use for sedation / endoscopic suites Smaller diameter scopes can be used Smaller diameter scopes can be used Enrol the gastroenterologists on this process Enrol the gastroenterologists on this process Real visualization / Reach the target Real visualization / Reach the target Risks Risks Potential risks of the transgastric closure Potential risks of the transgastric closure

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Operator – Diagnostic and non-organ removal Operator – Diagnostic and non-organ removal Gastroenterologists for diagnoses Gastroenterologists for diagnoses Surgeons for ablation Surgeons for ablation Keys to development Keys to development Find a simple and safe way to do the gastrotomy and to close it Find a simple and safe way to do the gastrotomy and to close it “10 min procedure for hepatic biopsy” “10 min procedure for hepatic biopsy”

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Timeline – Diagnostic and non-organ removal Timeline – Diagnostic and non-organ removal Actually Actually Not seeing as a target for the ones interested on NOTES Not seeing as a target for the ones interested on NOTES Technology is available Technology is available Still looking for different ways to do the gastrectomy and how to close it Still looking for different ways to do the gastrectomy and how to close it Up to 1-2y Up to 1-2y Define and standardize the method (grastrotomy) Define and standardize the method (grastrotomy) Run and maybe sponsor a bases trials Run and maybe sponsor a bases trials Over 3y Over 3y Adoption based on trial results Adoption based on trial results

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Obstacles for adoption – Diagnostic and non-organ removal Obstacles for adoption – Diagnostic and non-organ removal Lack of clinical knowledge about the safety of gastrotomy closure Lack of clinical knowledge about the safety of gastrotomy closure A simple and fast way to do that A simple and fast way to do that The established culture of image guided transcutaneous access to intra-abdominal biopsy and ablation The established culture of image guided transcutaneous access to intra-abdominal biopsy and ablation

SOLID ORGAN Opportunity for clinical utilization Opportunity for clinical utilization Enable technology needed – Organ removal Enable technology needed – Organ removal “Gastrotomy access kit” “Gastrotomy access kit” To open and close To open and close Flexible biopsy instruments for solid organs Flexible biopsy instruments for solid organs Flexible ablation instrumentation Flexible ablation instrumentation