Evolution of Embolization

Drs. Lussenhop and Spence first occluded a cerebral arteriovenous malformation under radiographic and catheter guidance in 1960. Charles Dotter is acknowledged as founder of the specialty from his landmark work on angioplasty, first published in circulation in 1960. Another who contributed early on was Dr. Baum, who developed techniques for controlling G-I bleeding using Vasopressin. Dr. Margolis first used the term interventional radiology and suggested guidelines for personnel and training in 1967.¹

Embolotherapy is one of the five cornerstones of interventional radiology: embolotherapy, opening circulation-angioplasty, draining solid organs, infusing drugs-thrombolytics, and performing venous access.

To continue with embolotherapy---following Drs. Lussenhops and Doppman in the USA, Japanese physicians developed selective catheter techniques for treating spinal cord AVMs. In 1972, Dr. Dotter and Dr. Rosch again developed techniques for controlling bleeding due to ulcer disease by embolizing autologous clots, and Dr. White et. al. first used this technique in 1974 to actually control ulcer bleeding with the patient surviving. Early in the 1970s, many radiologists began to use embolotherapy for lifesaving hemorrhages, etc.¹

Embosphere® Microspheres were developed from a material used in chromatography for the purification of biopharmaceuticals, and for cell culturing. Scientists and researchers developed head and neck applications for the microspheres at Lariboisiere Hopital in Paris in the early 1980's. Animal studies were initiated and clinical studies followed. By the early 1990's Embosphere Microspheres were being utilized in Europe.

In 1997, Embosphere Microspheres received the CE mark. To date, more than 15,000 patients have been treated with microspheres worldwide.

In April 2000, Embosphere Microspheres received clearance by the Food and Drug Administration for use in the treatment of arteriovenous malformations and hypervascularized tumors. Also in 2000, BioSphere Medical received an Investigational Device Exemption from the Food and Drug Administration to begin clinical studies for the use of Embosphere Microspheres in Uterine Artery Embolization. The final phase of this study has been completed with the final FDA submission underway for the clearance of a uterine fibroid embolization indication.

• Originally used for chromatography/cell culturing
• Head and neck applications developed at Hopital Lariboisiere, Paris
• Initial animal studies mid 1980s
• Initial clinical studies late 1980s
• Limited market availability early 1990s
• Received CE approval in 1997
• In April 2000, Embosphere Microspheres received FDA clearance
• In July 2001, EmboGold™ Microspheres received FDA clearance
• In March 2002, EmboGold Microspheres received both CE and Canadian approvals

¹ Robert I. White, MD, "Interventional Radiology: Reflections and Expectations", Radiology, 1987; 162: 593-600