a replacement for mmc?

2
Aeon Astron Europe B.V. Niels Bohrweg 11-13 CA 2333 Leiden, The Netherlands Tel: +31 71 3322280 Fax: +31 71 3322281 Email: [email protected] www.ologen.com For other customized models, please contact Aeon Astron. 0434 02-01-01-V01.0 © 2012 Aeon Astron Europe B.V. All rights reserved. 02-01-01-V01.0 ologen ® is a registered trademark owned by Body Organ Biomedical Corporation ologen ® Collagen Matrix MMC Non-teratogenic No significant risk known Physiologic, functional bleb Comparable surgical success rate No prior preparation required Save operation time Cytotoxic & teratogenic Non-selective cell death Thin bleb wall & avascular bleb Increased risk to infection Increased risk to endophthalmitis & blebitis Requires special handling & disposal Prolonged surgical time ologen ® A replacement for MMC? About ologen ® Collagen Matrix ologen ® Collagen Matrix is an advanced wound care device composed of a porous matrix of cross-linked atelocollagen and glycosaminoglycan. ologen ® Collagen Matrix is specifically designed to promote scar-less wound healing without the use of MMC in glaucoma & other ophthalmic surgeries. ologen ® Collagen Matrix enables scar-less wound healing with a prominent healthy vascular bleb as opposed to the MMC induced, thin, avascular bleb with late complications of bleb leakage, blebitis, and endophthalmitis. The dangers of handling MMC are avoided. The surgery is made more time efficient by eliminating the need for handling, application and disposal of MMC. Device Description - Type I atelocollagen with porous structure and pore diameter between 10 – 300 μm - Comprises > 90% atelocollagen and <10% Glycosaminoglycan (GAG) - Dry form scaffold Product Specification Product Shape Model number Specicaon 830601 6 mm (D) x 2 mm (H) 862051 12 mm (D) x 1 mm (H) 870051 10 mm (W) x 10 mm (L) x 2 mm (H) in surgeries such as glaucoma surgery Why should I replace MMC wtih ologen ® CM ologen ® CM Regenerative approach MMC Cytotoxic approach Highly porous scaffold provides spacious biological binding sites for fibroblasts which enables scar-less healthy tissue regeneration Non-selective cell death and apoptosis results in scar-less wound healing with thin avascular epithelium

Upload: others

Post on 12-Sep-2021

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: A replacement for MMC?

Aeon Astron Europe B.V.

Niels Bohrweg 11-13 CA 2333Leiden, The NetherlandsTel: +31 71 3322280Fax: +31 71 3322281 Email: [email protected]

For other customized models, please contact Aeon Astron.

0434

02-01-01-V01.0

© 2012 Aeon Astron Europe B.V. All rights reserved. 02-01-01-V01.0ologen® is a registered trademark owned by Body Organ Biomedical Corporation

ologen® Collagen Matrix MMC

N on-tera togen ic N o s ig n ifican t risk know n P h ysio log ic , fu nctional b leb C om parab le su rg ica l success ra te N o prior p reparatio n requ ired S ave opera tion tim e

C yto toxic & teratogen ic N on-selective ce ll death Th in b leb w all & avascu lar b leb Increased risk to in fection Increased risk to endophthalm itis &

b leb itis R equ ires specia l hand ling & d isposal P ro longed surg ica l tim e

ologen® Collagen Matrix MMC

N on-tera togen ic N o s ig n ifican t risk know n P h ysio log ic , fu nctional b leb C om parab le su rg ica l success ra te N o prior p reparatio n requ ired S ave opera tion tim e

C yto toxic & teratogen ic N on-selective ce ll death Th in b leb w all & avascu lar b leb Increased risk to in fection Increased risk to endophthalm itis &

b leb itis R equ ires specia l hand ling & d isposal P ro longed surg ica l tim e

ologen®

A replacement for MMC?

About ologen® Collagen Matrixologen® Collagen Matrix is an advanced wound care device composed of a porous matrix of cross-linked atelocollagen and glycosaminoglycan. ologen® Collagen Matrix is specifically designed to promote scar-less wound healing without the use of MMC in glaucoma & other ophthalmic surgeries. ologen® Collagen Matrix enables scar-less wound healing with a prominent healthy vascular bleb as opposed to the MMC induced, thin, avascular bleb with late complications of bleb leakage, blebitis, and endophthalmitis. The dangers of handling MMC are avoided. The surgery is made more time efficient by eliminating the need for handling, application and disposal of MMC.

Device Description- Type I atelocollagen with porous structure and pore diameter between 10 – 300 µm - Comprises > 90% atelocollagen and <10% Glycosaminoglycan (GAG) - Dry form scaffold

Product Specification

Product Shape Model number Specification

830601 6 mm (D) x 2 mm (H)

862051 12 mm (D) x 1 mm (H)

870051 10 mm (W) x 10 mm (L) x 2 mm (H)

Product Shape Model number Specification

830601 6 mm (D) x 2 mm (H)

862051 12 mm (D) x 1 mm (H)

870051 10 mm (W) x 10 mm (L) x 2 mm (H)

in surgeries such as glaucoma surgeryWhy should I replace MMC wtih ologen® CM

ologen® CMRegenerative approach

MMCCytotoxic approach

Highly porous scaffold provides spacious biological binding sites for fibroblasts which enables scar-less healthy tissue regeneration

Non-selective cell death and apoptosis results in scar-less wound healing with thin avascular epithelium

Page 2: A replacement for MMC?

ologen® CM is a safe and effective alternative to MMC

Ref: S. Cillino et al. Biodegradable collagen matrix implant vs mitomycin C as an adjuvant in trabeculectomy: a 24 month, randomized clinical trial. Eye (2011), 1-9

Standard procedure with loose suture technique

Surgical technique unchanged until the closure of scleral flap.

Suture scleral flap with single loose suture (1-2 mm edge open)

Place ologen® CM on top of scleral flap.

Close conjunctival flap and reform AC.

The pliable strength of ologen® CM facilitates bleb formation while providing resistance at the outlet of the scleral tunnel to prevent hypotony.

The Kaplan–Meier cumulative survival curves relating either the ≤21, ≤17, or ≤15 mmHg target IOP did not show significant intergroup differences for complete success rates (log-rank p=0.595, 0.999, and 0.349, respectively) or qualified success rates (log-rank p=0.131, 0.794, and 0.059, respectively)

Bleb comparison photos by Dr. S. Sarkisian

Bleb photos by Prof. S. Cillino

MMC ologen® 6 months

Features to successful bleb formation

Prominent vascular bleb without MMC

ologen® 24 months ologen® 32 months