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QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors and peripheral arteriovenous malformations.

The QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, non-resorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres size is: 30 to 60µm in containers (vials) containing 25 mg of dry microspheres, which can absorb aqueous media up to 64 times their dry state volume. The expansion rate is dependent on ionic concentration. When in contact with blood, non-ionic contrast media. or normal saline (NaCl 0.9%), QuadraSphere Microspheres expand to approximately 4 times their dry state diameter; equal to 64x volume. The QuadraSphere Microspheres have the following properties: - Retains spherical shape with consistent cross sectional diameter after reconstitution with aqueous-based solutions such as contrast media and 0.9% saline solution for predictable flow directed level of occlusion in the vasculature. - Rapidly absorbs contrast media and 0.9% saline solution. The spheres are positively charged, which allows them to bond ionically with negatively charged aqueous based solutions. - Compresses in the vessel lumen, providing more surface contact with vessel intima. - Expands up to four times the stated dry diameter when hydrated with non-ionic aqueous solutions, resulting in an increase in surface area contact for a more complete vessel occlusion. The principles of operation for the QuadraSphere Microspheres are the same as the predicate device. QuadraSphere Microspheres are permanent implantable devices and are designed for controlled, targeted embolization. The device is provided dry (in a vial) and must be rehydrated before use. The microspheres are injected into the target vessel with an intravascular catheter(s) to selectively occlude blood vessels. Contrast enhancement using commercially available ionic or non-ionic contrast media allows the embolization procedure to be monitored using fluoroscopy.

The BioSphere QuadraSphere™ Microspheres are intended for embolization of hypervascularized tumors and peripheral vascular arteriovenous malformations (AVMs). QuadraSphere Microspheres are indicated for embolization of hypervascularized arteriovenous malformations.

BioSphere Medical, Inc., QuadraSphere™ Microspheres are sterile, biocompatible, hydrophilic (absorbent), non-resorbable, acrylic copolymer microspheres. They are provided in three (nominal) microsphere sizes: 50 to 100 um, 100 to 150 um, and 150 to 200 um in containers (vials) containing 50 mg of the dry spheres.

The EmboCath® Plus Infusion Microcatheter is intended for: infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.

The EmboCath® Plus Infusion Microcatheter, same as its predicate device EmboCath Hydrophilic Catheter (K003105) is sterile, biocompatible, single use, peripheral vascular catheter constructed of a tapered reinforced shaft, inner lubricious lined lumen, hydrophilic outer surface, radiopaque marker and a standard luer adapter at the proximal end. The device will be provided in the following configurations: - Inner Diameter: 0.028 in. - Outer Diameters: 3 F proximally to 2.8 F distally - Lengths: 100 cm and 135 cm as indicated on product label . The EmboCath® Plus Infusion Microcatheter is a tapered 3.0-2.8F single lumen catheter designed to facilitate the access of distal vasculature over a guidewire. The catheter has a semi-rigid proximal shaft and becomes progressively more flexible toward the distal end. The shaft is reinforced, which provides improved torque transmission. The inner lumen is lined with a lubricious material to facilitate the movement of guidewires or other devices. The outer diameter of the catheter is coated with a hydrophilic surface to enhance the ability to navigate tortuous anatomy. The distal tip of the catheter has a single radiopaque marker to facilitate fluoroscopic visualization. The hub at the proximal end incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter lumen is 0.028 inches and guidewires measuring up to 0.025 inches (0.635 mm) in diameter are recommended.

The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.

The Sequitor™ Steerable Guidewire (.014" or .018") is a stainless steel guidewire with a polymer distal tip and a radiopaque distal tip that is shapeable. The distal 50 cm is coated with a hydrophilic coating. The guidewire length is depicted on the product label.

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.