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Bearing nsPVA Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

Bearing nsPVA particles are irregularly-shaped, hydrophilic, non-resorbable particles made of 100% crosslinked poly(vinyl alcohol). These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon placement through a catheter. The particles of the subject device, the Bearing nsPVA Express, are provided sterile and for single use in a 20 mL polycarbonate syringe with a luer-lock connector, individually packaged in a sterile foil peel pouch. Bearing nsPVA particles are calibrated and available in 7 size ranges (see table below) to enable the physician to choose depending on the diameter of the vessel to be embolized. Each syringe contains 100 mg of Bearing nsPVA particles.

Callispheres Embolic Microspheres and 8Spheres Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.

CalliSpheres and 8Spheres Embolic Microspheres are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, which are formed as a result of chemical modification on polyvinyl alcohol (PVA) materials. CalliSpheres and 8Spheres Embolic Microspheres consist of a macromer derived from polyvinyl alcohol (PVA), and are hydrophilic, non-resorbable, and are available in a range of sizes. The preservation solution is 0.9% sodium chloride solution. The water content of fully polymerized microsphere is 91% ~ 94%. Microspheres can tolerate compression of 30%. CalliSpheres Embolic Microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. 8Spheres Embolic Microspheres are undyed and with natural color. CalliSpheres and 8Spheres Embolic Microspheres are supplied sterile and packaged in sealed glass vials. CalliSpheres Embolic Microspheres and 8Spheres Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids. By blocking the blood supply to the target area, the tumor or malformation is starved of nutrients and shrinks in size. CalliSpheres and 8Spheres Embolic Microspheres can be delivered through typical microcatheters in the 1.7- 4 Fr range. At the time of use, CalliSpheres and 8Spheres Embolic Microspheres are mixed with a nonionic contrast agent to form a suspension solution. CalliSpheres and 8Spheres Embolic Microspheres are intended for single use and are supplied sterile and non-pyrogenic.

Embozene® Microspheres are intended for embolization of arteriovenous malformations, and hypervascular tumors, including uterine fibroids.

Embozene® Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as a hypervascular tumor (HVT) or arteriovenous malformation (AVM). Embozene® Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are color coded by size to allow easy identification of the different sizes. Embozene® Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes or vials are available in 1 ml or 2 ml microsphere volume.

Bearing ™ nsPVA Embolization Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

The Bearing™ nsPVA Embolization Particles are particles of They are noncross-linked polyvinyl alcohol (PVA). resorbable (permanent), hydrophilic and deformable particles that can be injected through a variety of catheters, depending on the size range, and are generally mixed with radiopaque contrast agent prior to their injection.

The Contour Embolization Particles are used for the embolization of peripheral hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

Contour Embolization Particles are artificial embolization devices. These devices are intended to provide vascular occlusion upon selective.placement via an angiographic catheter. Contour Embolization Particles are packaged sterile by gamma irradiation. Each vial is intended for single patient use only. The Contour™ Embolization particles are packaged in 1 cc dry volume per vial. The vials (glass with screw cap closure) are contained within a poly/Tyvek® pouch. The pouches are placed in boxes, in either a 2 vial/box or 5 vial/box configurations. All vials and boxes are appropriately labeled. The labels are color coded to differentiate between the different size ranges. The device is sterilized by gamma irradiation and labeled with a 26 month shelf life. The Contour Embolization Particles are available in a range of sizes as tabulated below: | Size | Minimum Compatible Catheter ID | |---|---| | 45-150 µm | 0.53 mm (0.021 in) (e.g. Renegade™ 18, Renegade STC) | | 150-250 µm | | | 250-355 µm | | | 355-500 µm | | | 500-710 µm | 0.69 mm (0.027 in) (e.g. Renegade Hi-Flo) | | 710-1000 µm | | | 1000-1180 µm | 1.12 mm (0.044 in) (e.g. Imager™ II Selective) | The Contour Embolization Particles are made of polyvinyl alcohol, which has been used for embolization procedures since 1972.

The Cook Polyvinyl Alcohol Foam Embolization Particles are intended for cmbolization of the blood supply to symptomatic utcrine fibroids.

Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles are small, flexible, particles made of cross-linked polyvinyl alcohol. The particles are packaged dry and are provided sterile in sealed vials. They are intended for delivery to the target site by a catheter under fluoroscopic control. Embolization particle sizes appropriate for use in symptomatic uterine fibroid treatment are 300-500 microns and 500-710 microns. There have been no changes in the design, dimensions, or materials of the device.

The Contour® Emboli PVA are used for the embolization of hypervascular tumors, leiomyoma uteri, and arteriovenous malformations. The FasTracker-325® Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast, and therapeutic agents, to the peripheral and coronary vasculature. This includes the delivery of the Contour® Emboli PVA to the uterine arteries for the purpose of occluding blood flow to leiomyoma uteri.

The Contour® Emboli PVA are used for the embolization of hypervascular tumors, leiomyoma uteri, and arteriovenous malformations. The FasTracker-325® Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast, and therapeutic agents, to the peripheral and coronary vasculature. This includes the delivery of the Contour® Emboli PVA to the uterine arteries for the purpose of occluding blood flow to leiomyoma uteri.

Embosphere® and EmboGold™ Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including and uterine fibroids. Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular turnors, and symptomatic uterine fibroids.

Embosphere® and EmboGold™ Microspheres are small, flexible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin. The microspheres are packaged in 0.9% saline and are provided sterile and nonpyrogenic. They are delivered to the target site by a catheter under fluoroscopic control. Both products are provided in six size ranges in order to allow physicians to choose the calibration necessary for the vessel being embolized. The size ranges available are: - 40-120 microns - 100-300 microns - 300-500 microns - 500-700 microns - 700-900 microns - 900-1200 microns Only microspheres of 500 microns or greater should be used for the embolization of uterine fibroids. The only difference between Embosphere® and EmboGold™ Microspheres is the colorization of the EmboGold™ Microspheres. Embosphere® Microspheres are translucent, although they are visible to the naked eye when in suspension. EmboGold™ Microspheres are purple/red in color for improved visibility during preparation and handling by the physician.