The unique bilayer Chondro-Gide ... - Geistlich Pharma AG · of Geistlich Pharma AG, which is...

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Geistlich and Collagen Geistlich was among the first pharmaceutical companies to apply collagen for medical use in the 1990s. With more than 160 years experience with bio-derived bone and collagen products, we applied our extensive knowledge of collagen and its biofunction- ality to develop the first collagen membrane to foster regeneration by providing a protective environ- ment for the cells and nutrients that are essential for regrowth. As experts in bone and tissue regeneration, we see tremendous potential for collagen in the future of regenerative medicine. That is why we have dedicated a team of biochemists, materials scien- tists, process engineers and other experts at our headquarters in Switzerland to focus exclusively on collagen, and to explore its other possible therapeutic applications. Through close relationships with the medical and scientific com- munity, we continue to share our knowledge and optimize our collagen-derived products. Finding ways to improve peoples’ qual- ity of life remains our larger goal. About Geistlich Surgery Geistlich Surgery produces inno- vative bio-derived matrix products for bone and cartilage, including Orthoss ® , Orthoss Collagen ® , and Chondro-Gide ® . Our products leverage the body’s own healing potential to regenerate bone and cartilage. Our focus is on helping people maintain and regain their quality of life. Geistlich Surgery is a business unit of Geistlich Pharma AG, which is headquartered in Switzerland. Entirely family owned since 1851, the company develops, produces, and markets medical devices for regenerative medicine and pharmaceuticals. From research and development to marketing, our operations are fully integrated under one roof, which enables us to oversee and optimize all levels of our business. Chondro-Gide ® at a Glance Key Benefits Bio-derived bilayer collagen membrane Backed by more than 8 years of positive clinical results Ready for use off the shelf Ideal for minimally invasive procedures Proven track record in ACI and bone marrow stimulating techniques Easy to handle – supple and tear-resistant Easy to cut (dry or wet) Can be glued or sutured into place Biocompatible and naturally resorbed Chondro-Gide ® has been proven to be an ideal collagen membrane, backed by more than eight years of clinical data. With its specially designed bilayer structure, Chondro-Gide ® provides a protective environment that fosters the growth of new cartilage. 1 To see the key benefits of Chondro-Gide ® and the Chondro-Gide ® product portfolio, turn the page. Headquarters Switzerland Geistlich Pharma AG Business Unit Surgery Bahnhofstrasse 40 CH-6110 Wolhusen Phone +41 41 492 55 55 Fax +41 41 492 56 39 [email protected] www.geistlich-surgery.com www.geistlich-surgery.com France Geistlich Pharma France SA Parc des Nations – Paris Nord II 385 rue de la Belle Etoile BP 43073 Roissy en France FR-95913 Roissy CDG Cedex Phone +33 1 48 63 90 26 Fax +33 1 48 63 90 27 [email protected] www.geistlich.fr Germany Geistlich Biomaterials Vertriebsgesellschaft mbH Schneidweg 5 D-76534 Baden-Baden Phone +49 7223 96 24 0 Fax +49 7223 96 24 10 [email protected] www.geistlich.de Italy Geistlich Biomaterials Italia S.r.l Via Castelletto, 28 I-36016 Thiene VI Phone +39 0445 370 890 Fax +39 0445 370 433 [email protected] www.geistlich.it 601382/1504/en © 2015 Geistlich Pharma AG — Subject to modifications The Surgeon’s Choice for Cartilage Regeneration The unique bilayer structure of Chondro-Gide ® provides the ideal conditions for cartilage regeneration.

Transcript of The unique bilayer Chondro-Gide ... - Geistlich Pharma AG · of Geistlich Pharma AG, which is...

Page 1: The unique bilayer Chondro-Gide ... - Geistlich Pharma AG · of Geistlich Pharma AG, which is headquartered in Switzerland. Entirely family owned since 1851, the company develops,

Geistlich and Collagen Geistlich was among the first pharmaceutical companies to apply collagen for medical use in the 1990s. With more than 160 years experience with bio-derived bone and collagen products, we applied our extensive knowledge of collagen and its biofunction-ality to develop the first collagen membrane to foster regeneration by providing a protective environ-ment for the cells and nutrients that are essential for regrowth.

As experts in bone and tissue regeneration, we see tremendous potential for collagen in the future of regenerative medicine. That is why we have dedicated a team of biochemists, materials scien-tists, process engineers and other experts at our headquarters in Switzerland to focus exclusively on collagen, and to explore its other possible therapeutic applications.

Through close relationships with the medical and scientific com-munity, we continue to share our knowledge and optimize our collagen-derived products. Finding ways to improve peoples’ qual-ity of life remains our larger goal.

About Geistlich Surgery Geistlich Surgery produces inno-vative bio-derived matrix products for bone and cartilage, including Orthoss®, Orthoss Collagen®, and Chondro-Gide®. Our products leverage the body’s own healing potential to regenerate bone and cartilage. Our focus is on helping people maintain and regain their quality of life.

Geistlich Surgery is a business unit of Geistlich Pharma AG, which is headquartered in Switzerland. Entirely family owned since 1851, the company develops, produces, and markets medical devices for regenerative medicine and pharmaceuticals. From research and development to marketing, our operations are fully integrated under one roof, which enables us to oversee and optimize all levels of our business.

Chondro-Gide® at a Glance

Key Benefits › Bio-derived bilayer collagen membrane› Backed by more than 8 years of positive

clinical results› Ready for use off the shelf › Ideal for minimally invasive procedures› Proven track record in ACI and bone marrow stimulating techniques › Easy to handle – supple and tear-resistant› Easy to cut (dry or wet)› Can be glued or sutured into place › Biocompatible and naturally resorbed Chondro-Gide® has been proven to be an ideal collagen membrane, backed by more than eight years of clinical data. With its specially designed bilayer structure, Chondro-Gide® provides a protective environment that fosters the growth of new cartilage.1

To see the key benefits of Chondro-Gide® and the Chondro-Gide® product portfolio, turn the page.

Headquarters SwitzerlandGeistlich Pharma AGBusiness Unit SurgeryBahnhofstrasse 40CH-6110 WolhusenPhone +41 41 492 55 55Fax +41 41 492 56 [email protected]

www.geistlich-surgery.com

FranceGeistlich Pharma France SAParc des Nations – Paris Nord II385 rue de la Belle EtoileBP 43073 Roissy en FranceFR-95913 Roissy CDG CedexPhone +33 1 48 63 90 26Fax +33 1 48 63 90 [email protected]

GermanyGeistlich BiomaterialsVertriebsgesellschaft mbHSchneidweg 5D-76534 Baden-BadenPhone +49 7223 96 24 0Fax +49 7223 96 24 [email protected]

ItalyGeistlich Biomaterials Italia S.r.lVia Castelletto, 28I-36016 Thiene VIPhone +39 0445 370 890Fax +39 0445 370 [email protected]

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The Surgeon’s Choice for Cartilage Regeneration

The unique bilayer structure of Chondro-Gide® provides the ideal conditions for cartilage regeneration.

Page 2: The unique bilayer Chondro-Gide ... - Geistlich Pharma AG · of Geistlich Pharma AG, which is headquartered in Switzerland. Entirely family owned since 1851, the company develops,

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The Chondro-Gide® acts as the roof of a biological chamber that forms around the defect and is filled with cells and blood. The chamber protects the cells and newly forming cartilage from shear forces while the cartilage regenerates and patients undergo rehabilita-tion. Supple and soft when wet, the Chondro-Gide® can be easily cut and wrapped to conform to defects in a variety of shapes.

Flexible and Strong, to Protect New Cartilage

Enhanced Microfracturing and Chondro-Gide®: Effective and Cost-Effective

A Proven Track Record of Success for AMIC® with Chondro-Gide®

Chondro-Gide® is a bilayer collagen membrane developed specifically for cartilage regeneration. Made from highly refined porcine collagen, it is produced in Switzerland following a rigorous quality assurance system to ensure its safety and quality.1

This illustration shows how Chondro-Gide® works to leverage the body’s own healing potential to regenerate human cartilage.

To learn more about Chondro-Gide® and cartilage regeneration, visit www.geistlich-surgery.com.

Bioengineered to Leverage the Body’s Own Healing Potential

1 Data on file at Geistlich Pharma AG, Wolhusen, Switzerland2 Gille, J. et al. (2010). Cartilage. I(I): 29–42.3 Fuss, M. et al. (2000). Ann Anat. 182(4): 303–310.4 Kramer, J. et al. (2006). Cell Moll Life Sci. 63: 616–626.5 Fulco, I. et al. (2014). Lancet. 384(9940): 337–346.6 Steck, E. et al. (2009). Stem Cells Dev. 18(7): 969–978.7 Mancini, D., Fontana, A. (2014). Int Orthop. 38(10): 2057–2064.8 Fontana, A., De Girolamo, L. (2015). Bone Joint J. 97–B.

Numerous clinical studies show that Chondro-Gide® is highly effective in surgical procedures commonly used to repair cartilage in the knee, talus, and hip, such as AMIC®, Matrix-Induced Autologous Chondrocyte Transplantation (MACT), and ACI. Below are findings from key studies.

AMIC® with Chondro-Gide® as Effective as MACT After 5 Years and Significantly Less Costly 7

Researchers compared long-term clinical outcomes in patients with medium-sized acetabular chondral defects from femoroacetabular im-pingement (FAI) who were treated using arthoscopic AMIC® and MACT. Both techniques were equally effective, but a one-step AMIC® reduced total treatment time and cost and also minimized morbidity, while providing the same benefits as a two-step MACT.

Excellent Clinical Results for AMIC® Patients after 5 Years, while Functional Outcomes Deteriorate for MFx Patients8

For AMIC® Patients, Significantly Less Pain and Stable Functionality More Than 8 Years After Surgery1

The data below is from the Geistlich AMIC® Knee Registry, which includes 18 participating centers in six countries.

Figure 2 Lysholm and VAS scores of patients over time (395 patients: 276 , 119 ; Ø age: 36 ± 12 years; Ø defect size : 3.3 ± 1.9 cm2)

Figure 1a Modified Harris Hip Score (mHHS) comparison of all patients treated either with MFx (n=77) or AMIC® (n=70); Figure 1b Impact of larger defect size (≥ 4 cm2) on the outcome MFx (n=35) and AMIC® (n=27)

Developed by Geistlich Surgery in colla-boration with leading surgeons, Autologous Matrix-Induced Chondrogenesis (AMIC®) uses microfracturing (MFx) in combination with Chondro-Gide® to stimulate the body’s own potential to heal itself. Chon-dro-Gide® stabilizes the super clot while also providing a protective environment for cartilage regeneration, even in larger defects. AMIC® is an effective and cost-effective treatment to repair cartilage lesions.

Backed by more than eight years of positive clinical outcomes, enhanced MFx with Chondro-Gide® is one of the most estab-lished first-line treatment options for cartilage lesions today.

A Smooth, Compact Top Layer

Chondro-Gide® is a CE-certified product that is manufactured according to a proprietary process developed and patented by Geistlich Pharma. As a privately held, fully inte-grated company, we oversee each step of the manufacturing process. A controlled production environment, rigorous in-process and end control ensure our ability to provide surgeons with a consistently high quality product they can rely on.

*Chondro-Gide® contains collagen: In very rare cases, allergies may occur.

Safety and Quality

The top layer of the Chondro-Gide® faces the joint cavity. It is made up of collagen fibers in a com-pact arrangement. Strong and cell-occlusive, this layer provides a protective barrier that prevents precious progenitor cells from diffusing into the joint space and getting lost to the regeneration process.1,3

This layer faces the defect. Rough and porous in appearance, it is made up of a loose network of collagen fibers, which have been engineered to provide a flexible but resistant matrix. The rough side of the Chondro-Gide® adheres to the defect, keeping the membrane in place.1

A Bio-Derived Collagen Membrane

The porous and rough bottom layer of the Chondro-Gide® provides an ideal environment for cell attachment and growth. Cells that are released through microfrac-turing or other marrow stimulation techniques or are introduced through Autologous Chondrocyte Implantation (ACI) attach themselves to this layer, where they proliferate and produce new tissue.4,5

Ideal Conditions for Cell Attachment and Growth

A Barrier to Prevent Cell Diffusion

The chondrocytes continue to grow and produce an extracellular matrix on the Chondro-Gide® membrane. Over time, the Chondro-Gide® is resorbed and replaced by new cartilage.2,6

A Stable Environment for Regeneration

A Rough, Porous Bottom Layer

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The Chondro-Gide® is placed on the defect with the smooth surface facing the joint cavity.

Depending on the defect size and site, the Chondro-Gide® can be glued or even sutured.

Chondro-Gide® is available in three sizes:

20 × 30 mm (30890.3)

30 × 40 mm (30915.5)

40 × 50 mm (30939.9)

A sterile aluminium template is included.

The subchondral bone at the base of the lesion is punctured and sufficient subchondral bleeding is verified.

Unique bilayer structure of Chondro-Gide® (SEM 100x)