DuraSeal TM Dural Sealant System PMA P040034. Presenters Eric Ankerud, J.D. – Confluent Surgical,...
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Transcript of DuraSeal TM Dural Sealant System PMA P040034. Presenters Eric Ankerud, J.D. – Confluent Surgical,...
DuraSealTM
Dural Sealant System
PMA P040034
DuraSealTM
Dural Sealant System
PMA P040034
PresentersPresentersEric 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 OverviewPresentation 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 OverviewCompany 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 SystemDuraSeal Dural Sealant System
Thumb piece
Syringes (2)
SprayerComponents
Powder Vial
Pre-Clinical SummaryPre-Clinical SummaryDuraSeal 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
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
“Water Tight” Closure Remains Elusive“Water Tight” Closure Remains Elusive
Meningitis – may lead to delayed neurologic complicationsProlonged hospitalization and increased patient cost Interference with wound healing (dehiscence)Abscess formationAdditional surgical intervention often required
CSF Leak Causes Postoperative Morbidity
CSF Leak Causes Postoperative Morbidity
Methods For Sealing Sutured Dural ClosureMethods For Sealing Sutured Dural Closure
Current MethodsFDA-Approved Devices Products Used Off Label
None NO STANDARD OF CAREFibrin Sealant (e.g. Tisseel)
Absorbable gelatin (e.g. Gelfoam)Collagen hemostatic agents (e.g.
Surgicel)Other bioadhesives (e.g. BioGlue)
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
US Pivotal Study ObjectiveUS Pivotal Study Objective
ProspectiveMulti-centerNon-randomized, single arm study11 participating sites
10 United States 1 Europe
Study DesignStudy Design
Follow-up ComplianceFollow-up CompliancePatients Enrolled
n=132
Intra-operativeScreen Failures
n=21
Patients Treated with DuraSealn=111
Immediate Post-operative Visit
(within 7 days of surgery)n=111
100% of patients evaluated
Patient Deathn=1 at 27 days
Post-op
6 Week Visitn=110
99% of patients evaluated
Patient Deathn=1 at 85 days
Post-op
3 Month Visitn=107
98% of patients evaluated
Lost toFollow-up
n=2
Primary Efficacy Analysis-Intraoperative Sealing Success
Primary Efficacy Analysis-Intraoperative Sealing Success
Analysis ResultsIntent To Treat*(includes 2 non-evaluable patients)
98.2% (109*/111)
[95% CI: 93.6-99.8]
Per Protocol(includes all evaluable patients)
100% (109/109) [95% CI: 96.7-100]
* Two patients had no leak after Valsalva maneuver, but pressure reached was only to 10 cm H2O and, therefore, were not evaluable
SummarySummary
Primary efficacy endpoint was met
Adverse events consistent in nature, frequency and severity for patients undergoing cranial surgery
ConclusionConclusion
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