Embosphere Microspheres Information and Microsphere Details - Treatment of Fibroid Tumor and Arteriovenous Malformation

Embosphere Microspheres

Embosphere Microsphere Pre-Filled Syringe

Microspheres were cleared by the FDA in April 2000 for marketing in the U.S. for hypervascularized tumors and arteriovenous malformations. Embolotherapy works by reducing blood flow to target areas of the body. The procedure is performed by injecting agents, usually particles, through a catheter and into the blood vessels that feed these target areas. By selectively blocking the target tissue's blood supply, the deprived tissue will either be destroyed or become devitalized, resulting in therapeutic benefit.

Our initial product, Embosphere® Microspheres have a number of beneficial properties that we believe make them well suited for these procedures. Because of their uniform, spherical shape and soft, slippery surface, our particles are easy to inject through small catheters, resulting in a more even distribution within the vessel network. We provide these products in a variety of precise sizes, so they can be selected to target occlusion of specific sized vessels to produce predictable results.

In November 2002, we received 510(k) clearance from the Food and Drug Administration, or FDA, to market our Embosphere Microspheres for UFE. Significant third-party clinical data and publications support the safety and effectiveness of the UFE procedure. We believe that a growing part of the medical community perceives UFE to be a reasonable alternative for most patients who now undergo hysterectomy for treatment of their fibroids. For these reasons, we believe the number of UFE procedures will increase. We were the first company to gain regulatory clearance to market a product for UFE in the United States. We continue to focus on ways to grow our Embosphere Microsphere business through our ASK4UFE™ awareness and education program and through physician training. On a worldwide basis, we continue to develop our sales and marketing organization to maintain our leadership position.

In addition to the FDA 510(k) clearance, we have received CE Mark approval in the European Union and approvals in Canada and Australia.

Available in a pre-filled syringe for procedural convenience and efficiency.

Embosphere Microsphere Pre-Filled Syringe