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DuraSeal TM Dural Sealant System PMA P040034 - PowerPoint PPT Presentation

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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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Presentation Transcript
  • 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

presentation overview
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.
company overview
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
duraseal dural sealant system

Powder Vial

Thumb piece



Syringes (2)

DuraSeal Dural Sealant System
pre clinical summary
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
water tight closure remains elusive
“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
csf leak causes postoperative morbidity
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
methods for sealing sutured dural closure
Methods For Sealing Sutured Dural Closure



Fibrin Sealant (e.g. Tisseel)

Absorbable gelatin (e.g. Gelfoam)

Collagen hemostatic agents (e.g. Surgicel)

Other bioadhesives (e.g. BioGlue)

us pivotal study objective
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

study design
Study Design
  • Prospective
  • Multi-center
  • Non-randomized, single arm study
  • 11 participating sites
    • 10 United States
    • 1 Europe
follow up compliance
Follow-up Compliance

Patients Enrolled


Intra-operativeScreen Failures


Patients Treated with DuraSeal


Immediate Post-operative Visit

(within 7 days of surgery)


100% of patients evaluated

Patient Death

n=1 at 27 days


6 Week Visit


99% of patients evaluated

Patient Death

n=1 at 85 days


Lost to



3 Month Visit


98% of patients evaluated

primary efficacy analysis intraoperative sealing success
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

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

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