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The VIA360™ Surgical System is indicated for delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

The VIA360™ Surgical System is a manually operated surgical instrument used by ophthalmologists to deliver controlled amounts of ophthalmic viscoelastic fluid into the anterior segment of the eye. The VIA360™ Surgical System is comprised of a surgical-grade stainless steel cannula and a nylon microcatheter. The cannula is attached to a nose piece that can be rotated to a desired position for use in either eye. The microcatheter is advanced and retracted up to 40 mm per cycle by rotating the scroll wheel. The microcatheter has patterned markings every 10 mm to help measure the extended length. A controlled amount of viscoelastic fluid is dispensed through multiple outlets located on the microcatheter's distal tip by depressing the scroll wheel or the surrounding button. An external reservoir is included for the purpose of priming the device. The device is single-use only.

The Kahook Dual Blade Glide is indicated to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open angle glaucoma.

The Kahook Dual Blade (KDB) Glide is a single-use, ophthalmic knife for use in adults. It is intended to remove a strip of trabecular meshwork tissue to allow for fluid outflow in glaucoma patients. The device is designed for ease of use and easy access to the structures within the eye. The blades are made of surgicalgrade stainless steel. The tip of the knife is pointed and allows for easy piercing of tissue. The ramp that the tip is attached to lifts tissue and exposes it to two parallel dual blades of the instrument, effectively remove a narrow strip of tissue.

The Ahmed® Glaucoma Valve Model FP7 is indicated for the management of refractory glaucomas, where previous surgical treatment has failed, or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medications, congenital or infantile glaucoma and refractory glaucomas resulting from aphakia or uveitis.

The Ahmed® Glaucoma Valve Model FP7 (AGV-FP7) (Modified) is a valved aqueous drainage implant designed to regulate intraocular pressure in eyes suffering from intractable glaucoma. The Ahmed® device is comprised of a silicone drainage tube that is connected to a valve mechanism. This valve mechanism is the same in the predicate AGV-FP7 (Original). The valve mechanism consists of a silicone sheet folded and pressed between two complimentary polypropylene plates. The valve mechanism is securely positioned in a pocket inside of a silicone endplate that serves to distribute the aqueous humor from the anterior chamber of the eye over the surface of the endplate. The valve in the AGV-FP7 (Modified) behaves like a variable resistor, decreasing resistance to allow more flow when intraocular pressure is high. When pressure is low, the resistance to fluid outflow is high and the valve closes, thereby preventing hypotony. By means of the valve mechanism, the AGV-FP7 (Modified) maintains intraocular pressure within the appropriate physiological range.

The Ahmed Glaucoma Valve Model FP8 is indicated for the management of refractory glaucomas where previous surgical treatment has failed or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medications, congenital or infantile glaucoma and refractory glaucomas resulting from aphakia or uveitis.

The Ahmed® is comprised of a silicone drainage tube that is connected to a valve mechanism. This valve mechanism is the same in the predicate AGV-FP8 (Original). The valve mechanism consists of a silicone sheet folded and pressed between two complimentary polypropylene plates. The valve mechanism is securely positioned in a pocket inside of a silicone endplate that serves to distribute the aqueous humor from the anterior chamber of the surface of the endplate. The valve in the AGV-FP8 (Modified) behaves like a variable resistor, decreasing resistance to allow more flow when intraocular pressure is high. When pressure is low, the resistance to fluid outflow is high and the valve closes, thereby preventing hypotony. By means of the valve mechanism, the AGV-FP8 (Modified) maintains intraocular pressure within the appropriate physiological range. In both the AGV-FP8 (Original) and AGV-FP8 (Modified), the silicone sheet is folded and pressed between two polypropylene plates. In both the predicate devices and the AGV-FP8 (Modified), the polypropylene bottom plate is separate from the silicone endplate material. The valve mechanism is inserted into a pocket in the silicone endplate to fixate the valve components to the endplate. Both the predicate devices and AGV-FP8 (Modified) have the same curvature as the average human eye at its equator and also protects the valve from blockage by fibrous tissue

The Streamline® Viscoelastic Injector is intended to deliver small amounts of viscoelastic fluid during Ophthalmic Surgery. The Streamline® Surgical System is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.

The Streamline® Viscoelastic Injector is a single use disposable device designed to deliver small amounts of viscoelastic fluid. The device consists of a single-use disposable device comprised of a surgical grade stainless steel cannula and a polymer handset, actuator button and priming port (Figure 1). The cannula is comprised of a long thin neck with an outer sleeve at its tip and allows access through a minimum 1.8 mm clear corneal incision. The cannula is long enough to reach across the eye 180 degrees from the clear corneal incision. The device outer sleeve is transparent which allows the dispensing cannula with a clearly identifiable color to be visible at 12X magnification. The priming port allows interfacing with commonly used viscoelastic containers used during priming and filling of the device. The actuator button is located at the top of the handset and is colored for easy identification and incorporates a slight depression giving the user a tactile feel and correct finger placement. Each actuation of the actuator button causes an internal mechanical cam to rotate causing a snap action which rapidly retracts the outer sleeve at the device's distal tip. This action allows the cannula to dispense viscoelastic fluid through opposing side outlets located at an acute angle from the perpendicular plane of tip (Figure 2). The length of the gear assembly allows for up to eight (8) total activations of the device. Each activation of the delivers approximately 7 µL of OVD and approximately 56 µL of OVD for the total maximum 8 activations allowed by the device. Once all activations are completed the gear assembly will have reached the end of travel and cannot be reset. Additionally, activation of the actuator button causes the priming port to disengage from the fluid pathway, to prevent re-priming of the device. This prevents the device from further priming preventing re-use. Materials used to manufacture the Streamline® Viscoelastic Injector are of medical grade quality and no toxic substances are used in the manufacturing process. The materials used in the Streamline® Viscoelastic Injector were selected from materials safe for use in a clinical setting. These materials include stainless steel, polycarbonate, ABS polymer and silicone.

The AHMED® ClearPath glaucoma drainage device is indicated for the management of refractory glaucoma where previous surgical treatment has failed or is not expected to provide satisfactory results. Such refractory glaucoma may include but is not limited to: neovascular glaucoma, congenital or infantile glaucoma, and refractory glaucoma resulting from aphakia or uveitis.

The AHMED® ClearPath Glaucoma Drainage Device is a non-valved drainage device designed to shunt aqueous in eyes suffering from refractory glaucoma. Two models CP250 are available covering surface areas of approximately 250mm². The implant consists of a medical grade silicone tube secured to a medical grade silicone episcleral plate near the anterior suture points. The anterior suture points are located on the anterior side of the plate, flanking each side of the tubing track. The silicone plate is barium impregnated to increase ultrasound resolution and identification with CT scan, MRI and plain skull films. The plate conforms to the shape of the globe at its equator and provides a surface from which fluid can be dispersed. Each AHMED® ClearPath is supplied with a 23-gauge hypodermic needle and a 2-inch polypropylene ripcord (pre-loaded in the lumen of the tube) in a sterile, sealed double- pouch. The supplied needle and ripcord are for optional use and are available to be incorporated into the implantation procedure per the surgeon's usual routine. The device is for single use only.

The Ahmed® Glaucoma Valve Model FP8 is indicated for the management of refractory glaucomas, where previous surgical treatment has failed, or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medication, congenital or infantile glaucoma, and refractory glaucomas resulting from aphakia or uveitis.

The Ahmed® Glaucoma Valve Model FP8 (AGV-FP8) is a valved aqueous drainage implant designed to regulate intraocular pressure in eyes suffering from intractable glaucoma. The Ahmed® device is comprised of a silicone drainage tube that is connected to a valve mechanism. This valve mechanism is the same in the predicate AGV-FP7. The valve mechanism consists of a silicone sheet folded and pressed between two complimentary polypropylene plates. The valve mechanism is securely positioned in a pocket inside of a silicone endplate that serves to distribute the aqueous humor from the anterior chamber of the eye over the surface of the endplate. The valve in the AGV-FP8 and the predicate AGV-FP7 behaves like a variable resistor, decreasing resistance to allow more flow when intraocular pressure is high. When pressure is low, the resistance to fluid outflow is high and the valve closes, thereby preventing hypotony. By means of the valve mechanism, the AGV-FP8 and the predicate AGV-FP7 maintain intraocular pressure within the appropriate physiological range.

The Ahmed™ Glaucoma Valve is indicated for the management of refractory glaucomas, where previous surgical treatment has failed, or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medications, congenital or infantile glaucoma, and refractory glaucomas resulting from aphakia or uveitis

The Ahmed™ Glaucoma Valve Model FP7 (AGV-FP7) is a valved aqueous drainage implant designed to regulate intraocular pressure in eyes suffering from intractable glaucoma. The Ahmed™ device is comprised of a silicone drainage tube that is connected to a valve mechanism. This valve mechanism is the same in the AGV-FP7 and the predicate AGV-S2. The valve mechanism consists of a silicone sheet folded and pressed between two complimentary polypropylene plates. The valve mechanism is securely positioned in a pocket inside of a silicone endplate that serves to distribute the aqueous humor from the anterior chamber of the eye over the surface of the endplate. The valve in the AGV-FP7 behaves like a variable resistor, decreasing resistance to allow more flow when intraocular pressure is high. When pressure is low, the resistance to fluid outflow is high and the valve closes, thereby preventing hypotony. By means of the valve mechanism, the AGV-FP7 maintains intraocular pressure within the appropriate physiological range. In both the AGV-S2 and AGV-FP7, the silicone sheet is folded and pressed between two polypropylene plates. In the AGV-S2, the bottom polypropylene plate is comprised of the polypropylene endplate body. In the AGV-FP7, the polypropylene bottom plate is separate from the silicone endplate material. The valve mechanism is inserted into a pocket in the silicone endplate to fixate the valve components to the endplate. Additional differences include stiffening ribs in the posterior half of the AGV-FP7 to add stiffness to the flexible endplate, The other predicate device, the Baerveldt Glaucoma Implant (BGI) also consists of a flexible silicone endplate which shares some features with the AGV-FP7, though the BGI endplate is larger in area. The AGV-FP7 endplate has the same curvature as the average human eye at its equator and also protects the valve from blockage by fibrous tissue. The endplate is made of flexible silicone. Inflammation and scarring around flexible silicone implants in animal ocular tissue was less pronounced than that found around rigid polypropylene.

The Ahmed™ Glaucoma Valve is indicated for the management of refractory qlaucomas, where previous surgical treatment has failed, or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medication, congenital or infantile dlaucoma, and refractory glaucomas resulting from aphakia or uveitis.

The Ahmed™ Glaucoma Valve (AGV) S3 is a valved aqueous drainage implant designed to regulate intraocular pressure in eyes suffering from intractable glaucoma. The Ahmed™ device is comprised of a silicone drainage tube that is connected to a valve membrane. The valve membrane is sandwiched between a top plate made of polyprolylene and a complementary bottom plate made of polypropylene. The bottom plate is extended to provide for aqueous distribution and drainage. The valve body conforms to the shape of the globe at its equator and protects the valve from blockage by fibrous tissue growth. The Ahmed Valve Model M4 valve system is exactly the same as the Models S2 and S3. The M4 valve system is enclosed within a porous material (MEDPOR®) made of polyethylene (MEDPOR® is well established as a safe material and has been approved by the FDA for ocular use).

The Ahmed™ Glaucoma Valve is indicated for the management of refractory glaucomas, where previous surgical treatment has failed, or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medication, congenital or infantile glaucoma, and refractory glaucomas resulting from aphakia or uveitis.

The Ahmed™ Glaucoma Valve Bi-plate is a modification of an already approved device called the Ahmed™ Glaucoma Valve (AGV™) Ref. 510 (k) 925636 dated November 12, 1993. The Ahmed™ Glaucoma Valve (AGV™) is an ophthalmic implant for use in intractable Glaucoma. The device features a specially engineered, one way silicone membrane valve system designed to prevent collapse of the anterior chamber (AC) due to hypotony (abnormally low intraocular pressure) and to reduce excessive intraocular pressure by venting aqueous out of the anterior chamber through this control one way valve. The AGV™ implant consists of a silicone drainage tube, a polypropylene valve body to house the valve membrane, and to protect it from occlusion due to fibrosis. All materials used in the manufacturing of this device are of medical grade quality. No metallic or toxic substances are used in the manufacturing of this device. The AGV™ is terminally sterilized by gamma radiation. The AGV™ has a surface area of 184mm².