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Ologen™

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Ologen™ Collagen Matrix Has US FDA Approval

For wound healing such as in glaucoma & other ophthalmic surgeries
Procedure Videos
Technology Today PDF download

Post operation Comparison of Ologen vs. Mitomycin-C, Bleb Comparison by: Dr. Sarkisian.

Ologen 2 Years Post Op Compare Ologen Mitomycin-C
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About ologen

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Ologen™ Collagen Matrix Implant has been developed to increase the success rate of the wound healing processes in surgeries including glaucoma filtration surgery and other selected ocular procedures. The super Matrix may significantly increase the success rate by reducing fibrosis and thus eliminating MMC induced complications. ologen™ may normalize the subconjunctival wound healing process, incidentally maintaining a functional bleb with normalized conjunctiva, biodegraded within an anticipated 90 days.

Ologen™ is a biodegradable and implantable scaffold Collagen Matrix Implant. It's func- tion is to induce a regenerative non-scarring wound healing process without the use of anti-fibrotic agents. The Matrix improves regeneration and tissue re-modeling, preventing scar formation. The implantation of ologen™ is a simple process requiring that the Ophthalmologist perform the operation based on traditional methods and techniques with minimal changes to suture techniques (such as the trabeculectomy). ologen™ is implanted over the scleral flap, with the surgeon making sure to carefully suture both Tenon's capsule and Conjunctiva over the Ologen making a water tight seal of the wound. The postoperative management is performed as usual with scleral flap sutures being released or cut early in the postoperative course to insure adequate aqueous is being absorbed by the collagen matrix..

A Safe and Effective Treatment for wound management in surgeries, including Glaucoma Filtration Surgery and Pterygium.

The principal of a Collagen Matrix Implant is to induce the fibroblast to randomize which leads to normalized wound healing. The Collagen’s porous structure may also work as a reservoir, or a buffering system, helping to promote controlled drainage. Ologen natu- rally randomizes the growth of myofibroblasts and can create a new physiologic envi- ronment between the anterior chamber and subconjunctival space. Collagen, being distinct from anti-metabolites which reduces the physiologic barrier through inhibition, maintains the physiologic barrier through regeneration, which may allow for a normal- ized, low and diffuse functional bleb, which may also normalize the dynamic aqueous balance which could create a healthy conjunctival system.

post operation 6 months

6 months

post operation 6 months

12 months

2yearsSmall

Download Very High Resolution Collagen Matrix Bleb 6 months post op.JPG
Download Very High Resolution Collagen Matrix Bleb 12 months post op.JPG
Download Very High Resolution Collagen Matrix Bleb 24 months post op JPG

 

1 year post op ologen OS BHF

1 year post op with ologen

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2 year post op ologen OS BHF

2 year post op with ologen

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Surgical Procedure:

ologen™ - Implanting procedure for Trabeculectomy Procedure Videos

 Preparation of the conjunctival     Create the fistula
1. Preparation of the conjunctival and scleral flaps.     2. Create the fistula beneath the scleral flap.
Suture the scleral flap loosely     implant ologen
3. Suture the scleral flap loosely with one single stitch.     4. Implant ologen™ directly on the top of the scleral flap.
Close the conjunctival flap    
5. Close the conjunctival flap.     6. Reform the anterior chamber.

Comparison:

Currently, the most common management of filtration surgery (trabeculectomy) is having intra- or postoperative anti-proliferative therapy (such as 5-fluorouracil or mitomycin-C). This particular remedy decreases the likelihood of an aggressive postoperative fibroblast-mediated scarring process. These antimetabolites are radiomimetic, may cause widespread cell death, induce acellularity and apoptosis, alter bleb morphology, and increase risk of complications such as hypotony, maculopathy, corneal toxicity, wound leakage, infections and/or endophthalmitis.

Traditional ologen™
•    Reduces the physiologic barrier - MMC or 5 FU
•    Focus on the Scleral incision most implants may create long term risks, such as thin conjunctiva, soft orbit, hypotony– and the damage of ciliary body
•    Hypotony–this may occur if the scleral flap is not man- aged or properly sutured. Long term complications and side effects may occur

•    The use of the Collagen Matrix for wound management may also help to maintain the subcon- junctival space supporting the prevention of scarring while supporting and maintaining the size of the bleb...even after partial degradation
•    Naturally maintains a physiologic barrier allow- ing for natural and supportive regeneration (normal epithelium, stroma, goblet cells, vessels)
•    Prevention of hypotony – The use of Collagen for wound management may also apply dynamic pressure of the scleral wound, allowing for natural dynamic fluid control and assist in maintaining a physiologic conjunctival barrier
•    Ologen Collagen Matrix is fully bio-degradable

 

Complications of using Antimetabolite Therapy:

 

Possible Complications of using MMC Negative Attributes to Using MMC
• Hypotony :
IOP<5 mmHg
• Ifncidence : 3.0–37.3%
• Can lead to Maculopathy especially in young myopes or with Longer exposure and other high risk patients
• Intraocular Toxicity
• Corneal endothelial
• Ciliary Body
• Wound Leakage
• Delayed wound healing
• Thin avascular blebs
• Infection & Endophthalmitis
• Creates difficult Post Operative Patient Management with Possible Late Complications that can cause permanent decreased vision
• Significant Risk in Handling as MMC is not only Toxic but also Teratogenic
• Increase Time in the Operating Room
• Preparation & Handling Time Critical
• Care and Handling of Surgical Instruments that are in contact with the Anti-metabolite as well as significant Disposal Requirements

 

Device Description:

Formula
–Collagen-glycosaminoglycan Matrix
?Collagen?90% and Chondroitin 6-sulfate?10%?
–Disk with scaffold structure
–Material: Collagen, CG polymer with approximate 95% pore
volume subtraction.
–Pore diameter is 20?200?m.ologen™ - Implanting procedure for Trabeculectomy
ologen™

Model Description
830601 2.0 mm (H) x 6.0 mm (D) ±10%mm
862051 1.0 mm (H) x 12.0 mm (D) ±10%mm
870051 10 mm (L) x 10 mm (W) x 2 mm (H) ±10%mm
861051 12/20 (ID/OD) x (H) 1 mm (donut shape) ±10%mm

Collagen Matrix for wound management in Surgery:

1. Failed Trabeculectomy
2. Severe conjunctival scarring following surgery
3. Primary Trabeculectomy
4. Refractory glaucoma
5. Tube, Valve or Shunt Surgery
6. Pterygium Surgery

Features & Benefits:

– Guides the fibroblast to grow through the matrix pore randomly for the prevention of scar formation
– May act as aqueous reservoir creating a buffer to prevent flat or shallow anterior chamber
– Facilitating proper surgical wound healing
– No anti-metabolites are needed at the surgical wound site, which may reduce sideeffects.
– The surgical technique is not altered except small changes in the Suture tension
reduction & ologen™ on top of scleral flap under Tenons and Conjunctiva.
– The use of the Collagen Matrix may drastically decrease wound contraction and
promote the formation of a nearly normal sub-conjunctival Stroma.
– Ologen™ has shown to have long term effectiveness for surgical procedures.

Contraindication:

ologen™ is contraindicated under the following condition:
? Known allergic reaction to collage™

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