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DuraGen Plus

Product catalog summary

Overview: The document discusses DuraGen Plus Dural Regeneration Matrix, a product by Integra LifeSciences Corporation, designed for spine surgery. It highlights the product's specifications, applications, and safety profile.

Specifications:

Ultra Pure Collagen™: Ensures no foreign body reaction and supports fibrin clot formation for a biological seal.
Excellent Conformability: Allows precise graft approximation at the dural margin.
Optimized Resorption: The matrix resorbs at the same rate as new tissue forms, facilitating integration.
Engineered Porosity: Promotes tissue integration without encapsulation.

Procedures and Applications:

DuraGen Plus is used as an onlay graft in spinal duraplasty, providing a simple technique for precise placement between the dura and overlying tissues.
It conforms easily to complex surfaces and remains in place during healing, preventing cerebrospinal fluid (CSF) leakage.
Specifically applied in duraplasty following tumor resection, such as laminectomy for spinal Schwannoma removal.

Safety Profile:

Over 300,000 implants have been used for dural repair with minimal adhesion formation and effective CSF leakage protection.
No foreign body reactions reported in clinical trials, indicating good immunological tolerance.

Adverse Events: Possible complications include CSF leaks, infection, delayed hemorrhage, and adhesion formation. In clinical evaluations, postoperative infection rates were similar to control groups, with minimal adhesion formation observed.

Manufacturing Standards: The collagen used in DuraGen Plus meets US and European standards for animal tissue sourcing and pathogen inactivation, ensuring safety and compliance.

Ordering Information: The document provides catalog numbers and sizes for ordering DuraGen Plus, ranging from 1x1 inch to 5x7 inches.

Catalog excerpts

Spine solutions from the leader in regenerative technology Dura protection for spine surgery

Open the catalog to page 1

DuraGen Plus Dural Regeneration Matrix, the most advanced Dural Regeneration Matrix for spine THE DURAL REGENERATION MATRIX RESORPTION RATE MATCHES THE GROWTH RATE OF NEW TISSUE DuraGen Plus' porous architecture is specifically tailored for application in spinal duraplasty. DuraGen Plus meets the requirements of an onlay, delivers superior results Requirements Ultra Pure Collagen™ No reported foreign body reaction, ﬁbrin clot formation for biological seal Excellent Conformability Ensures graft approximation at the dural margin Optimized Resorption Matrix resorbs at the same rate as new tissue...

Open the catalog to page 2

Superior safety profile* • Over 300,000 implants for dural repair.1 • Minimal adhesion formation only following significant disruption of pia-arachnoid.1,2 • Effective protection against cerebrospinal fluid (CSF) leakage with sutureless closure.1,2 • Immunologically well tolerated—no foreign body reactions reported in all clinical trials.1,2 DuraGen Plus, the onlay graft of choice for spinal dural repair • Provides a simple technique for precise placement of the matrix between the dura and overlying tissues in spinal procedures3,4,5 • Handles like normal soft tissue, easily conforming to the...

Open the catalog to page 3

DuraGen Plus™ Ordering Information Catalog Number Spine solutions from the leader in regenerative technology Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 www.Integra-LS.com Customer Service: 800-997-4868 (USA and Canada) 800-654-2873 (USA and Canada) 609-275-0500 (Outside USA) 609-275-5363 (Fax) Sizes shown in inches at actual size. Adverse Events Possible complications can occur with any neurosurgical procedure and include cerebrospinal fluid leaks, infection, delayed hemorrhage and adhesion formation. In clinical evaluations involving 1,096 patients, postoperative...

Open the catalog to page 4

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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