Publicidad
Idiomas disponibles
Idiomas disponibles
Although the AHMED
the published clinical literature summarizes the performance of the predicate device Baerveldt Glaucoma Implant.
o Budenz, Donald L., et al. "Five-year treatment outcomes in the Ahmed Baerveldt comparison study."
Ophthalmology 122.2 (2015): 308-316.
The following additional clinical literature is referenced in support of differences in design of the AHMED
ClearPath as compared to the predicate Baerveldt Glaucoma Implant.
• Placement of Device: This study was conducted to determine optimal positioning of various glaucoma
drainage devices posterior to the limbus while maintaining a safe distance relative to the optic nerve.
o Kahook, Malik Y., et al. "Location of glaucoma drainage devices relative to the optic nerve." British
Journal of Ophthalmology 90.8 (2006): 1010-1013.
• Implant Design – Ridge: The following studies evaluated the safety and effectiveness of the AGV-FP7
reference device to the predicate Baerveldt Glaucoma Implant and indicate that a lack of a ridge does not
significantly impact implant performance.
o Budenz, Donald L., et al. "Five-year treatment outcomes in the Ahmed Baerveldt comparison study."
Ophthalmology 122.2 (2015): 308-316.
o Budenz, Donald L., et al. "Postoperative complications in the Ahmed Baerveldt comparison study during
five years of follow-up." American Journal of Ophthalmology 163 (2016): 75-82.
• Use of Ripcord for Tube Occlusion: A ripcord for optional use is provided within the tube lumen of the
Ahmed ClearPath device. Tube occlusion via intraluminal ripcord is a common technique to prevent
early postoperative hypotony in non-valved glaucoma drainage devices. Below are examples of medical
publications that discuss this technique, its effectiveness and its impact on implant performance.
o Sherwood, Mark B., and M. Fran Smith. "Prevention of early hypotony associated with Molteno implants
by a new occluding stent technique." Ophthalmology 100.1 (1993): 85-90.
o An, Selena J., et al. "Scheduled postoperative ripcord removal in Baerveldt 350 implants corresponds
with increased complications: a prospective, randomized trial." Investigative Ophthalmology & Visual
Science 59.9 (2018): 2073-2073.
ClearPath has not been clinically evaluated for performance, the following reference in
®
Clinical Data:
7.
®
Publicidad
