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DuraSeal TM Dural Sealant System PMA P040034

DuraSeal TM Dural Sealant System PMA P040034. Presenters. Eric Ankerud, J.D. – Confluent Surgical, Inc. Vice President, Clinical, Regulatory, and Quality Patrick Campbell, Ph.D. – Confluent Surgical, Inc. Vice President, Research & Development John Tew, M.D. – Mayfield Clinic

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DuraSeal TM Dural Sealant System PMA P040034

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  1. DuraSealTMDural Sealant SystemPMA P040034

  2. Presenters • Eric Ankerud, J.D.– Confluent Surgical, Inc. Vice President, Clinical, Regulatory, and Quality • Patrick Campbell, Ph.D. – Confluent Surgical, Inc. Vice President, Research & Development • John Tew, M.D. – Mayfield Clinic Professor, Department of Neurosurgery, University of Cincinnati • G. Rees Cosgrove, M.D. – Massachusetts General Hospital Associate Professor of Surgery, Harvard Medical School • Harry van Loveren, M.D. –Tampa General Hospital Professor and Chairman, Director of Skull Base and Cerebrovascular Surgery, University of South Florida

  3. Presentation Overview • Project Overview–Eric Ankerud, J.D. • Technology Overview–Pat Campbell, Ph.D. • Project Rationale–John Tew, M.D. • US Pivotal Trial Results– G. Rees Cosgrove, M.D. • Safety Evaluation– Harry van Loveren, M.D.

  4. Company Overview • Mission:Development of in-situ polymerized biomaterials to address the unmet needs of surgical wound healing including surgical tissue sealing, post surgical adhesion prevention, and hemostasis • Founded:1998 • People:30 employees • Facility:Waltham, Massachusetts • Products:Commercially available OUS

  5. Powder Vial Thumb piece Sprayer Components Syringes (2) DuraSeal Dural Sealant System

  6. Pre-Clinical Summary • DuraSeal is non-toxic and safe, up to 40X human dose • DuraSeal is not neurotoxic, and allows complete neodura formation • Intraoperative and postoperative sealing efficacy demonstrated in relevant canine model • Ability to image DuraSeal has been demonstrated, and has complete absorption over 8 weeks

  7. “Water Tight” Closure Remains Elusive • Achieving “water tight” closure is basic tenet of neurosurgical practice • Controlling intraoperative leakage is important to prevent CSF leakage and development of postoperative complications: • Suture pinholes and space between sutures act as “one-way” valve for CSF leakage • Subdural collections of CSF fluid may develop into pseudomeningoceles and overt incisional leaks with potential for serious post-operative sequelae

  8. CSF Leak Causes Postoperative Morbidity • Meningitis – may lead to delayed neurologic complications • Prolonged hospitalization and increased patient cost • Interference with wound healing (dehiscence) • Abscess formation • Additional surgical intervention often required

  9. Methods For Sealing Sutured Dural Closure None NO STANDARD OF CARE Fibrin Sealant (e.g. Tisseel) Absorbable gelatin (e.g. Gelfoam) Collagen hemostatic agents (e.g. Surgicel) Other bioadhesives (e.g. BioGlue)

  10. US Pivotal Study Objective To evaluate the safety and effectiveness of the DuraSeal Dural Sealant System as an adjunct to sutured dural repair during cranial surgery to provide watertight closure

  11. Study Design • Prospective • Multi-center • Non-randomized, single arm study • 11 participating sites • 10 United States • 1 Europe

  12. Follow-up Compliance Patients Enrolled n=132 Intra-operativeScreen Failures n=21 Patients Treated with DuraSeal n=111 Immediate Post-operative Visit (within 7 days of surgery) n=111 100% of patients evaluated Patient Death n=1 at 27 days Post-op 6 Week Visit n=110 99% of patients evaluated Patient Death n=1 at 85 days Post-op Lost to Follow-up n=2 3 Month Visit n=107 98% of patients evaluated

  13. Primary Efficacy Analysis-Intraoperative Sealing Success * Two patients had no leak after Valsalva maneuver, but pressure reached was only to 10 cm H2O and, therefore, were not evaluable

  14. Summary • Primary efficacy endpoint was met • Adverse events consistent in nature, frequency and severity for patients undergoing cranial surgery

  15. Conclusion In the patient population evaluated, the benefits associated with the use of the DuraSeal Sealant outweigh any potential risks associated with the use of the device

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