INTEGRA LIFESCIENCES HOLDINGS CORP (IART)
Integra LifeSciences Holdings Corporation is a medical technology company focused on the creation, production, and global distribution of advanced surgical implants and instruments. These products are utilized across various medical fields, including neurosurgery, limb reconstruction, and general surgical procedures. The company operates through two primary business segments: Codman Specialty Surgical and Tissue Technologies. The Codman Specialty Surgical division offers a comprehensive range of neurosurgical and neuro-critical care products. This includes specialized equipment for tissue ablation, dural repair solutions, cerebral spinal fluid management systems, intracranial monitoring tools, and cranial stabilization devices. Additionally, this segment provides surgical headlamps, various instrumentation, and supports these offerings with asset management software, technical assistance, and after-market services. Integra also supplies an extensive catalog of approximately 40,000 surgical instrument designs, along with a wide selection of surgical and lighting products. Its clientele spans hospitals, surgical centers, and extends to dental, podiatry, and veterinary practices. The Tissue Technologies segment specializes in innovative regenerative technology products for the treatment of both acute and chronic wounds. It further provides surgical tissue repair solutions for a multitude of applications, such as hernia repair, peripheral nerve protection and regeneration, and tendon reconstruction. This encompasses a broad array of offerings for skin and wound repair, plastic and reconstructive surgery products, bone grafting materials, and specialized nerve and tendon repair products. Integra LifeSciences distributes its diverse product portfolio internationally, reaching markets throughout the United States, Europe, Asia Pacific, and other global regions. Distribution is managed directly through its dedicated sales forces and various other channels, serving a wide array of healthcare entities including hospitals, integrated health networks, group purchasing organizations, individual clinicians, surgery centers, and other healthcare providers. Founded in 1989, Integra LifeSciences Holdings Corporation is headquartered in Princeton, New Jersey.
Sector: Surgical & Medical Instruments & Apparatus
Industry: Medical - Devices
Integra LifeSciences Holdings Corporation
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Completed
PleuraSeal Post Market Study (Europe)
Standard Tissue Closure Techniques, PleuraSeal Lung Sealant System
Lung Disease, Pulmonary Lobectomy
NCT00704171Enrollment121StartJan 2008Primary CompletionDec 2008CompletionDec 2008 - Phase 3Completed
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
Sinuplasty
Chronic Sinusitis
NCT00231062Enrollment115StartApr 2005Primary CompletionJun 2006CompletionJun 2006 - Phase 3Terminated
PleuraSeal Pivotal Study (US)
PleuraSeal Sealant System, Standard Tissue Closure Techniques
Open Thoracotomy
NCT00748124Enrollment230StartAug 2008Primary CompletionSep 2010CompletionApr 2011 - Phase 3Terminated
Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers
DSC127, placebo vehicle gel
Diabetic Foot Ulcers
NCT01830348Enrollment266StartFeb 2013Primary CompletionDec 2015CompletionDec 2015 - Phase 3Terminated
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
0.03% DSC127 topical gel
Diabetic Foot Ulcer
NCT01840085Enrollment261StartDec 2015Primary CompletionDec 2015CompletionDec 2015 - Phase 3Terminated
Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers
DSC127, placebo vehicle gel
Diabetic Foot Ulcers
NCT01849965Enrollment396StartApr 2013Primary CompletionDec 2015CompletionDec 2015 - Phase 2/3Completed
Evaluation of the Tympanostomy Tube Delivery System
tympanostomy tube
Otitis Media With Effusion, Acute Otitis Media
NCT01202578Enrollment53StartSep 2010Primary CompletionNov 2010CompletionDec 2010 - Not applicableTerminated
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
DuraGen Plus Adhesion Barrier Matrix
Spinal Injuries, Adhesions
NCT00387829Enrollment347StartOct 2006Primary CompletionDec 2010CompletionDec 2011 - Not applicableTerminated
Study to Evaluate Safety & Effectiveness of Vascular Sealant System
Gelfoam/Thrombin, VascuSeal
Peripheral Vascular Disease
NCT00439309Enrollment69StartApr 2007Primary CompletionMay 2008CompletionMay 2008 - Not applicableCompleted
Study to Evaluate Safety & Effectiveness of Spinal Sealant
Spinal Sealant, Standard of Care
Cerebrospinal Fluid Leakage, Subdural
NCT00444067Enrollment98StartMay 2007Primary CompletionAug 2009CompletionAug 2009 - Not applicableCompleted
Study to Evaluate Safety and Effectiveness of Spinal Sealant
Spinal Sealant System, Standard of care
Spinal Procedure Requiring Dura Incision
NCT00594035Enrollment158StartSep 2005Primary CompletionFeb 2008CompletionApr 2008 - Not applicableCompleted
DuraSeal Sealant Post Market Study
DuraSeal Dural Sealant System, Standard of Care
Elective Cranial Procedures With Dural Incision
NCT00704340Enrollment237StartSep 2005Primary CompletionMay 2009CompletionMay 2009 - Not applicableCompleted
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
Stratus Microflow Ethmoid Spacer
Sinusitis
NCT00791934Enrollment63StartAug 2008Primary CompletionNov 2011CompletionNov 2011 - Not applicableCompleted
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
SprayShield™
Fibroid, Myoma +1
NCT00891657Enrollment15StartNov 2008Primary CompletionMay 2009CompletionMay 2009 - ObservationalCompleted
Large Abdominal Hernia Repair With SurgiMend 3.0
-
Hernia
NCT00892333Enrollment122StartApr 2009Primary CompletionJul 2014CompletionJul 2014 - Not applicableCompleted
Balloon Sinus Dilation In Office or OR
FESS instruments with or without balloon treatment, Balloon Sinuplasty
Chronic Sinusitis
NCT00939393Enrollment72StartApr 2008Primary CompletionJun 2009CompletionJul 2010 - Not applicableCompleted
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
Relieva™ Balloon Sinuplasty™ System
Chronic Sinusitis
NCT00939471Enrollment44StartApr 2007Primary CompletionJul 2009CompletionMay 2010 - Not applicableCompleted
Clinical Study of the Tympanostomy Tube Delivery System
Acclarent Tympanostomy Tube Delivery System
Otitis Media With Effusion
NCT00939796Enrollment16StartMar 2009Primary CompletionJun 2009CompletionJul 2009 - Not applicableCompleted
Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus
Iontophoresis System (Acclarent)
Acute Otitis Media, Chronic Otitis Media +1
NCT00941993Enrollment109StartApr 2008Primary CompletionJan 2011CompletionJan 2011 - Not applicableTerminated
An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
SprayShield Adhesion Barrier System, Good Surgical Technique Alone
Ulcerative Colitis, Familial Polyposis
NCT01002287Enrollment11StartOct 2009Primary CompletionOct 2010CompletionMay 2011 - Not applicableCompleted
Singapore Tympanostomy Tube Delivery System Study
Tympanostomy Tube Delivery System
Otitis Media
NCT01046877Enrollment25StartDec 2008Primary CompletionAug 2010CompletionJun 2011 - Not applicableCompleted
Anesthetizing the Tympanic Membrane in Healthy Volunteers
Acclarent Iontophoresis System
Evaluate Performance and Reliability of Iontophoresis System
NCT01047904Enrollment21StartAug 2009Primary CompletionNov 2009CompletionNov 2009 - Not applicableTerminated
Clinical Evaluation of the Ethmoid Sinus Spacer
Ethmoid Sinus Spacer
Sinusitis, Chronic Rhinosinusitis
NCT01054703Enrollment14StartApr 2007Primary CompletionNov 2007CompletionNov 2007 - Not applicableCompleted
A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
Integra® Dermal Regeneration Template, Conventional Wound Therapy
Neuropathic Diabetic Ulcer - Foot
NCT01060670Enrollment545StartApr 2010Primary CompletionJun 2014CompletionJun 2014 - ObservationalCompleted
Optimization and Refinement of Technique in In-Office Sinus Dilation 2
Relieva Balloon Sinuplasty System
Sinusitis
NCT01107379Enrollment203StartApr 2010Primary CompletionJan 2012CompletionJul 2012
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Completed | Standard Tissue Closure Techniques, PleuraSeal Lung Sealant System | NCT00704171 |
| Phase 3 | Completed | Sinuplasty | NCT00231062 |
| Phase 3 | Terminated | PleuraSeal Sealant System, Standard Tissue Closure Techniques | NCT00748124 |
| Phase 3 | Terminated | DSC127, placebo vehicle gel | NCT01830348 |
| Phase 3 | Terminated | 0.03% DSC127 topical gel | NCT01840085 |
| Phase 3 | Terminated | DSC127, placebo vehicle gel | NCT01849965 |
| Phase 2/3 | Completed | tympanostomy tube | NCT01202578 |
| Not applicable | Terminated | DuraGen Plus Adhesion Barrier Matrix | NCT00387829 |
| Not applicable | Terminated | Gelfoam/Thrombin, VascuSeal | NCT00439309 |
| Not applicable | Completed | Spinal Sealant, Standard of Care | NCT00444067 |
| Not applicable | Completed | Spinal Sealant System, Standard of care | NCT00594035 |
| Not applicable | Completed | DuraSeal Dural Sealant System, Standard of Care | NCT00704340 |
| Not applicable | Completed | Stratus Microflow Ethmoid Spacer | NCT00791934 |
| Not applicable | Completed | SprayShield™ | NCT00891657 |
| Observational | Completed | - | NCT00892333 |
| Not applicable | Completed | FESS instruments with or without balloon treatment, Balloon Sinuplasty | NCT00939393 |
| Not applicable | Completed | Relieva™ Balloon Sinuplasty™ System | NCT00939471 |
| Not applicable | Completed | Acclarent Tympanostomy Tube Delivery System | NCT00939796 |
| Not applicable | Completed | Iontophoresis System (Acclarent) | NCT00941993 |
| Not applicable | Terminated | SprayShield Adhesion Barrier System, Good Surgical Technique Alone | NCT01002287 |
| Not applicable | Completed | Tympanostomy Tube Delivery System | NCT01046877 |
| Not applicable | Completed | Acclarent Iontophoresis System | NCT01047904 |
| Not applicable | Terminated | Ethmoid Sinus Spacer | NCT01054703 |
| Not applicable | Completed | Integra® Dermal Regeneration Template, Conventional Wound Therapy | NCT01060670 |
| Observational | Completed | Relieva Balloon Sinuplasty System | NCT01107379 |
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