PRESERFLO™ MicroShunt:
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Introducing PRESERFLO™ MicroShunt COMMAND IOP

Safer, more consistent outcomes.

Designed for stability

Precisely engineered from ultra-stable SIBS material, the PRESERFLO™ MicroShunt is a state-of-the-art device with an innovative design for simple implantation and controlled IOP reduction.1

Highly Effective IOP Reduction

With 4 out of 5 patients achieving and maintaining IOP ≤14 mmHg at 3 years, the PRESERFLO™ MicroShunt gives you the power to bring your patients’ IOP levels under control.1

Low complication rates

The PRESERFLO™ MicroShunt has a favourable safety profile compared with trabeculectomy, with a low risk of complications and no reported cases of serious long-term adverse events.1

Results for you and your patients

By minimizing the need for post-operative interventions and reducing the number of medications needed by patients, the PRESERFLO™ MicroShunt may help reduce the treatment burden associated with primary open-angle glaucoma (POAG).1

PRESERFLO™ MicroShunt is made from uniquely biocompatible SIBS

SIBS (Poly(styrene-block-isobutylene-block-styrene)) is a uniquely biocompatible, degradation-resistant material proven to minimize inflammation, scarring, and encapsulation.2

biocompatible SIBS
  • Polystyrene
  • Polyisobutylene
  • Polystyrene
biocompatible SIBS

SIBS: Backed by 20 Years of Science

Research on the SIBS material has been ongoing for more than 20 years, with 10 years spent developing the material and 10 more years spent testing and implanting the PRESERFLO™ MicroShunt device.2

Clinically
Proven

Safely used as a
cardiac stent coating
for over 15 years3

Implanted in
>1 million patients

Ultra-Stable &
Biocompatible

Minimal foreign-body reaction

Designed to resist degradation

Soft &
Flexible

Conforms to the
curvature of the eye

Minimizes erosion

Synthetic
Composition

Offers a universal
choice to patients
and clinicians

PRESERFLO™ MicroShunt: The Device2

3 mm distal tail enables formation of posterior bleb 1 mm fin prevents migration and periannular leakage Beveled tip allows clearance of debris to prevent blockage 8.5 mm length and 70 µm lumen optimize aqueous flow and decrease hypotony risk Actual Size
3 mm distal tail enables formation of posterior bleb 1 mm fin prevents migration and periannular leakage Beveled tip allows clearance of debris to prevent blockage 8.5 mm length and 70 µm lumen optimize aqueous flow and decrease hypotony risk Actual Size

Precisely engineered for predictable IOP control, the PRESERFLO™ MicroShunt offers substantial IOP reductions from medicated baseline in a safer, more predictable procedure for patients with POAG.1

How PRESERFLO™ MicroShunt Treats High Intraocular Pressure

Ab externo implantation offers unique benefits that enable consistent outcomes1

Ab externo approach enables full visualization of MMC* administration and device placement

Ab externo approach enables full visualization of
MMC* administration and device placement

Sub-Tenon’s placement provides insulation from erosion1

Sub-Tenon’s placement provides insulation from erosion1

Length of device enables creation of posterior, low-lying, diffuse bleb

Length of device enables creation
of posterior, low-lying, diffuse bleb

* MMC: Mitomycin C

Eye Diagram

PRESERFLO™ MicroShunt

Surgical Procedure

The PRESERFLO™ MicroShunt is an implantable glaucoma drainage device made of an extremely flexible SIBS [poly(Styrene-block-IsoButylene-block-Styrene)] polymer with a tube of 350 μm outer diameter and a lumen of 70 μm. It has triangular fins that prevent migration of the tube into the AC. The device is designed to be implanted under the subconjunctival/Tenon space.

Surgeons should be well familiarized with the device with proper training before implanting PRESERFLO™ MicroShunt Mechanism of Action.

CONTENTS

PRESERFLO™ MicroShunt (1) – 3mm Scleral Marker (1) – MANI Ophthalmic Knife (1mm Slit Angle Knife) (1) – Lasik Shields (3) – Marker Pen (1) – 25G Needle (1)

Clinical Outcomes

14.3 mmHg

Mean post-op IOP on 0.6 mean medications at month 121

74%

Lower rate of hypotony requiring intervention vs. trabeculectomy through month 121

72%

Of patients were medication-free at month 121

39%

Lower rate of interventions vs. trabeculectomy through month 121

PRESERFLOTM MicroShunt achieved substantial IOP reductions from medicated baseline1

25 20 15 10 5 0 Screening Day 1 Day7 Month 1 Month 3 Month 6 Month 12 Mean IOP, mmHg (95% CI) Mean IOP, from screening to month 12,* (n=132) (n=395) 21.1 21.1 17.5 16.5 13.5 13.8 14.5 14.3 9.2 9.4 12.0 10.8 11.4 11.1 PRESERFLOTM MicroShunt Trabeculectomy 14.3 mmHg mean post-op IOP 29% mean IOP reduction from medicated baseline At month 12

72% of PRESERFLO™ MicroShunt patients were medication-free at month 121

PRESERFLO™ MicroShunt patients (n=384) Trabeculectomy (n=125) 100% 80% 50% 40% 20% 0% Month 12 Medication-free patients 84.8% 71.6% 72% medication-free Medication-free patients1
PRESERFLO™ MicroShunt patients (n=384) Trabeculectomy (n=125) 3.5 3.0 2.5 2.0 1.5 0.5 Month 12 0 Screening Mean number of glaucoma medications 0.3 0.6 3.0 3.1 <1 mean post-op medication dependency at month 12 Mean medication at screening and month 121

Lower rates of select glaucoma-related events compared with trabeculectomy at month 12

PRESERFLO™ MicroShunt exhibited lower rates of select glaucoma-related adverse
events compared with trabeculectomy at month 12

74%

LOWER RATE OF HYPOTONY REQUIRING INTERVENTION

Adverse Event

PRESERFLO™ MicroShunt (n=395)

Trabeculectomy
(n=131)
Hypotony (IOP <6 mmHg at any time) 28.9% 49.6%
Persistent hypotony* 7.1% 21.2%
Hypotony requiring intervention† 2.0% 7.6%
Total bleb leaks 8.9% 14.5%
Late bleb leaks (after month 1 follow-up visit) 3.0% 6.9%

*Defined as IOP <6 mmHg present on 2 consecutive follow-up visits after the month 3 visit

†Defined as hypotony that cannot be adequately treated by medication alone, thus requiring a secondary physical intervention

Lower overall rate of post-operative interventions compared with trabeculectomy at month 121

39%

LOWER RATE OF POST-OPERATIVE INTERVENTIONS

Post-op intervention

PRESERFLO™ MicroShunt
(n=395)

Trabeculectomy
(n=132)
Any post-op intervention 40.8% 67.4%
Medical intervention (post-op introduction of any antiglaucoma medication) 37.2% 31.8%
Needling of the bleb with or without the use of an injected antifibrotic 19.0% 8.3%
Qualified glaucoma re-operation in the study eye 14.9% 11.4%
Other glaucoma surgery to reduce IOP 3.3% 1.5%
Laser suture lysis before any secondary trabeculectomy 0% 52.3%

Indications For Use

The PRESERFLO™ MicroShunt Glaucoma Drainage System is intended for reduction of intraocular pressure in eyes of patients with primary open angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery.

Contraindications

The implantation of the PRESERFLO™ MicroShunt is contraindicated if one or more of the following conditions exist: BACTERIAL CONJUNCTIVITIS; BACTERIAL CORNEAL ULCERS; ENDOPHTHALMITIS; ORBITAL CELLULITIS; BACTEREMIA OR SEPTICEMIA; ACTIVE SCLERITIS; UVEITIS; SEVERE DRY EYE; SEVERE BLEPHARITIS; PRE-EXISTING OCULAR OR SYSTEMIC PATHOLOGY THAT, IN THE OPINION OF THE SURGEON, IS LIKELY TO CAUSE POSTOPERATIVE COMPLICATIONS (E.G. SEVERE MYOPIA AND THIN CONJUNCTIVA) FOLLOWING IMPLANTATION OF THE DEVICE; PATIENTS DIAGNOSED WITH ANGLE CLOSURE GLAUCOMA.

Health Canada Approved

PRESERFLO™ MicroShunt

References:

  1. Data on file. Glaukos Inc. 2021.
  2. Pinchuk L, Riss I, Batlle JF, et al. The development of a micro-shunt made from poly(styrene-block-isobutylene-block-styrene) to treat glaucoma. J Biomed Mater Res Part B. 2017;105B:211-221. doi:10.1002/jbm.b.33525.
  3. Sadruddin O, Pinchuk L, Angeles R, Palmberg P. Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review. Eye Vis (Lond). 2019;6:36. doi:10.1186/s40662-019-0162-1.
  4. Data on file. Glaukos Inc. 2017.