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ONE CYPASS® MICRO-STENT IS ALL IT TAKES TO CONNECT TO SAFE, CONSISTENT, LONG-TERM IOP CONTROL

SUPERIOR OUTCOMES ACROSS CLINICAL TRIAL ENDPOINTS

  • The two-year COMPASS trial is the largest randomized, controlled MIGS trial completed to date, and included >500 patients with baseline and terminal washout1
  • Implanted at the time of cataract surgery, the CyPass® Micro-Stent was shown to lower IOP for more patients than cataract surgery alone1
AT TWO YEARS:  
72.5%  OF EYES
treated with the CyPass® Micro-Stent achieved a ≥20% reduction in IOP vs 58.0% with cataract surgery alone (primary endpoint) (p=0.003)2

61.2%  OF EYES
treated with the CyPass® Micro-Stent maintained an unmedicated diurnal IOP between 6 mmHg and 18 mmHg vs 43.5% with cataract surgery alone (p=0.0005)2
32%  MORE EFFECTIVE
at lowering IOP than cataract surgery alone
(-7.0 mmHg vs -5.3 mmHg) (p<0.0001)2

93%  OF RESPONDERS*
in the CyPass® Micro-Stent group were medication-free2

*Those patients who attained an unmedicated mean diurnal IOP reduction of 20% or more as compared with baseline in the absence of IOP-affecting surgery during the study.

Study design: Study design: Prospective, randomized, multicenter clinical trial in patients (N=505) with open-angle glaucoma undergoing cataract surgery. Patients were randomized to receive phacoemulsification and CyPass® Micro-Stent implantation (n=374) or phacoemulsification alone (n=131), and all patients were followed for two years. The primary outcome measure was the proportion of eyes with unmedicated diurnal IOP reduction ≥20% at two years vs unmedicated baseline IOP. Secondary outcome measures included mean change in 24-month diurnal IOP from baseline and 24-month unmedicated mean IOP (between 6 mmHg and 18 mmHg) vs cataract surgery alone. Medication use at 24 months was also analyzed. The primary and secondary effectiveness analyses were performed using the intent-to-treat (ITT) population.1


A SMART DESIGN FOR OPTIMAL PERFORMANCE 

  • Flexible polyimide material curves along the applier’s guidewire during insertion and straightens once placed1
    — This creates a tenting effect that promotes drainage of aqueous fluid through the device3
  • 64 fenestrations help to maximize aqueous outflow1,2
  • A series of retention rings keeps the device in place and guides proper depth of insertion1,2

The CyPass® Micro-Stent is magnetic resonance (MR) safe: the implant is constructed of polyimide material; a non-conducting, non-metallic, non-magnetic polymer that poses no known hazards in all magnetic resonance imaging environments.2

SEE HOW THE CYPASS® MICRO-STENT WORKS IN THE SUPRACILIARY SPACE


A MINIMALLY INVASIVE, INTUITIVE IMPLANTATION

  • Straightforward insertion with a curved guidewire works in harmony with the eye’s anatomy1
  • The CyPass® Micro-Stent spares the conjunctiva, and avoids the formation of a filtering bleb1

Ab-interno insertion into the supraciliary space.1


Clearly visible retention rings provide guidance for insertion.1,2


CONTACT YOUR ALCON SALES REPRESENTATIVE
TO SIGN UP FOR CYPASS® MICRO-STENT TRAINING.


VIEW IMPORTANT PRODUCT INFORMATION FOR:

CYPASS® MICRO-STENT IMPORTANT PRODUCT INFORMATION

CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

INDICATION: The CyPass® Micro-Stent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG).

CONTRAINDICATIONS: Use of the CyPass® Micro-Stent is contraindicated in the following circumstances or conditions: (1) in eyes with angle-closure glaucoma; and (2) in eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle.

MRI INFORMATION: The CyPass® Micro-Stent is magnetic resonance (MR) safe: the implant is constructed of polyimide material, a non-conducting, non-metallic, non-magnetic polymer that poses no known hazards in all magnetic resonance imaging environments.

WARNINGS: Gonioscopy should be performed prior to surgery to exclude peripheral anterior synechiae (PAS), rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard.

PRECAUTIONS: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the CyPass® Micro-Stent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, in eyes with significant prior trauma, chronic inflammation, eyes with an abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, pseudophakic eyes with glaucoma, eyes with uveitic glaucoma, eyes with pseudoexfoliative or pigmentary glaucoma, eyes with other secondary open-angle glaucomas, eyes that have undergone prior incisional glaucoma surgery or cilioablative procedures, eyes with laser trabeculoplasty performed ≤3 months prior to the surgical screening visit, eyes with unmedicated IOP less than 21 mmHg or greater than 33 mmHg, eyes with medicated IOP greater than 25 mmHg, in the setting of complicated cataract surgery with iatrogenic injury to the anterior or posterior segment, and when implantation is without concomitant cataract surgery with IOL implantation for visually significant cataract. The safety and effectiveness of use of more than a single CyPass® Micro-Stent has not been established.

ADVERSE EVENTS: In a randomized, multicenter clinical trial comparing cataract surgery with the CyPass® Micro‑Stent to cataract surgery alone, the most common postoperative adverse events included: BCVA loss of 10 or more letters at 3 months after surgery (8.8% for the CyPass® Micro-Stent vs. 15.3% for cataract surgery only); anterior chamber cell and flare requiring steroid treatment 30 or more days after surgery (8.6% vs. 3.8%); worsening of visual field mean deviation by 2.5 or more decibels (6.7% vs. 9.9%); IOP increase of 10 or more mmHg, 30 or more days after surgery (4.3% vs. 2.3%); and corneal edema 30 or more days after surgery, or severe in nature (3.5% vs. 1.5%).

ATTENTION: PLEASE REFER TO THE INSTRUCTIONS FOR A COMPLETE LIST OF CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS.

References: 1. Vold S, Ahmed IIK, Craven ER, et al. Two-year COMPASS trial results: supraciliary microstenting with phacoemulsification in patients with open-angle glaucoma and cataracts. Ophthalmology. 2016;123(10):2103-2112. 2. CyPass® Micro-Stent Instructions for Use. 3. Saheb H, Ianchulev T, Ahmed IIK. Optical coherence tomography of the suprachoroid after CyPass Micro-Stent implantation for the treatment of open-angle glaucoma. Br J Ophthalmol. 2014;98:19-23.