12-month pivotal study safety data1

XEN® Gel Stent has a favorable risk/benefit ratio, with low rates of intraoperative complications and postoperative vision-threatening adverse events1

Intraoperative complications1

0%

  • 0% surgical complications
  • 0% shallow anterior chamber with peripheral iridocorneal touch
  • 0% flat anterior chamber with iridocorneal touch extending to the pupil
  • 0% choroidal hemorrhage or effusion
  • 0% hyphema
  • 0% conjunctival perforation
  • 0% iris/lens damage

Persistent hypotony*

0%

Defined as IOP < 6 mm Hg at 2 visits > 30 days apart

Transient hypotony*

24.6%

Defined as IOP < 6 mm Hg at any time

Postoperative complications of clinical interest

  • 1.5% bleb leak (without operative room or slit lamp revision)
  • 0% bleb leak (with operative room or slit lamp revision)
  • 3.1% choroidal effusion (extending posterior to equator, without blood)
  • 0% choroidal effusion (all others)
  • 0% chronic pain (present > 3 months)
  • 1.5% corneal edema grade 3 or grade 4 (> 30 days postoperatively)
  • 0% endophthalmitis
  • 4.6% hyphema (≥ 2 mm in height [layered] at any time)
  • 0% hyphema (present or arising > 30 days)
  • 0% hypotony maculopathy
  • 1.5% macular edema
  • 32.3% needling procedure
  • 0% ptosis
  • 0% significant iris injury or atrophy
  • 0% strabismus
  • 0% vitreous hemorrhage
  • 9.2% wound leak/dehiscence

*No clinically significant consequences were associated with hypotony, such as choroidal effusions, suprachoroidal hemorrhage, or hypotony maculopathy. IOP < 6 mm Hg was defined as an adverse event, regardless of whether there were any associated complications or sequelae related to the low pressure. Thirteen cases occurred at the 1-day visit; there were no cases of persistent hypotony, and no surgical intervention was required for any case of hypotony.

XEN® Gel Stent provided effective and sustained IOP reduction without the need for additional surgery for most patients (88%) at 1 year.1

INDICATIONS

The XEN® Glaucoma Treatment System (XEN® 45 Gel Stent preloaded into a XEN® Injector) is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

XEN® Gel Stent is contraindicated in angle-closure glaucoma where angle has not been surgically opened, previous glaucoma shunt/valve or conjunctival scarring/pathologies in the target quadrant, active inflammation, active iris neovascularization, anterior chamber intraocular lens, intraocular silicone oil, and vitreous in the anterior chamber.

WARNINGS

XEN® Gel Stent complications may include choroidal effusion, hyphema, hypotony, implant migration, implant exposure, wound leak, need for secondary surgical intervention, and intraocular surgery complications. Safety and effectiveness in neovascular, congenital, and infantile glaucoma has not been established. Avoid digital pressure following implantation of the XEN® Gel Stent to avoid the potential for implant damage.

PRECAUTIONS

Examine the XEN® Gel Stent and XEN® Injector in the operating room prior to use. Monitor intraocular pressure (IOP) postoperatively and if not adequately maintained, manage appropriately. Stop the procedure immediately if increased resistance is observed during implantation and use a new XEN® system. Safety and effectiveness of more than a single implanted XEN® Gel Stent has not been studied.

ADVERSE EVENTS

The most common postoperative adverse events included best-corrected visual acuity loss of ≥ 2 lines (≤ 30 days 15.4%; > 30 days 10.8%; 12 months 6.2%), hypotony IOP < 6 mm Hg at any time (24.6%; no clinically significant consequences were associated, no cases of persistent hypotony, and no surgical intervention was required), IOP increase ≥ 10 mm Hg from baseline (21.5%), and needling procedure (32.3%).

Caution: Federal law restricts this device to sale by or on the order of a licensed physician. Please click here for the full Directions for Use. Please call 1-800-433-8871 to report an adverse event.

Click here for XEN® Gel Stent Indications and Important Safety Information 

INDICATIONS

The XEN® Glaucoma Treatment System (XEN® 45 Gel Stent preloaded into a XEN® Injector) is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

XEN® Gel Stent is contraindicated in angle-closure glaucoma where angle has not been surgically opened, previous glaucoma shunt/valve or conjunctival scarring/pathologies in the target quadrant, active inflammation, active iris neovascularization, anterior chamber intraocular lens, intraocular silicone oil, and vitreous in the anterior chamber.

WARNINGS

XEN® Gel Stent complications may include choroidal effusion, hyphema, hypotony, implant migration, implant exposure, wound leak, need for secondary surgical intervention, and intraocular surgery complications. Safety and effectiveness in neovascular, congenital, and infantile glaucoma has not been established. Avoid digital pressure following implantation of the XEN® Gel Stent to avoid the potential for implant damage.

PRECAUTIONS

Examine the XEN® Gel Stent and XEN® Injector in the operating room prior to use. Monitor intraocular pressure (IOP) postoperatively and if not adequately maintained, manage appropriately. Stop the procedure immediately if increased resistance is observed during implantation and use a new XEN® system. Safety and effectiveness of more than a single implanted XEN® Gel Stent has not been studied.

ADVERSE EVENTS

The most common postoperative adverse events included best-corrected visual acuity loss of ≥ 2 lines (≤ 30 days 15.4%; > 30 days 10.8%; 12 months 6.2%), hypotony IOP < 6 mm Hg at any time (24.6%; no clinically significant consequences were associated, no cases of persistent hypotony, and no surgical intervention was required), IOP increase ≥ 10 mm Hg from baseline (21.5%), and needling procedure (32.3%).

Caution: Federal law restricts this device to sale by or on the order of a licensed physician. Please click here for the full Directions for Use. Please call 1-800-433-8871 to report an adverse event.

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