OAK RIDGE, Tenn., Jan. 20, 1997 --Mallinckrodt Medical Inc. has licensed an invention from the Department of Energy's (DOE) Oak Ridge National Laboratory (ORNL) that could save more than 100,000 people from having additional heart surgery.
Of the 400,000 balloon angioplasty procedures that are performed annually in the United States, 30 percent of patients require additional surgery because their arteries clog up again, but the use of a special radioactive isotope -- rhenium-188 -- prevents this arterial blockage from forming.
Rhenium 188 is available from the tungsten-188/rhenium-188 generator developed in the ORNL Nuclear Medicine program.
Although a variety of pharmacological approaches are being explored to inhibit restenosis after balloon angioplasty, ionizing radiation has been found to be one of the only non-surgical and easily performed procedures which is effective. This can be accomplished using the technology developed at ORNL and licensed to Mallinckrodt.
A highly concentrated form of rhenium is needed for this type of procedure and is provided by a special ion exchange system developed at ORNL. The concentration method, developed by researchers at the laboratory, uses rhenium-188 for the radiation of the coronary arteries after angioplasty. Rhenium treatment following balloon angioplasty cuts the rate of restenosis, or reblockage of the arteries, significantly.
The licensing agreement gives the St. Louis-based company sole commercial, field-of-use rights for the invention. With restenosis occurring in 25 percent to 30 percent of angioplasty patients, "the invention will help save time, lives and costs -- for both hospitals and patients," said Russ Knapp, principal investigator who led the team.
The technology was developed at ORNL by Knapp, Arnold Beets, Saed Mirzadeh and Stefan Guhke of the Life Sciences Division. Robert Mills, vice president and general manager of Mallinckrodt Interventional, said that Mallinckrodt is excited about obtaining the license "because it expands our capabilities in working with rhenium radioisotopes."
Knapp emphasized this new use of rhenium 188 is a cost-effective alternative to other radioisotopes. Besides treating restenosis, rhenium-188 is used in physician-approved trials in collaboration with ORNL for the treatment of bone pain from skeletal metastases of cancers of the breast, lung and prostate.
The clinical application of rhenium-188 for coronary artery irradiation has been approved by the U.S. Food and Drug Administration for use at Columbia University Medical Center in New York. The first patient was treated in September. Sixty patients will be enrolled in this Phase I study. Initial results will be available early this year.
Mallinckrodt, established in 1867, is an international radiopharmaceutical manufacturer with corporate offices and research and production facilities located in St. Louis. Mallinckrodt has eight business divisions serving markets in human health care, animal health and specialty chemicals.
"This is a perfect example of how a partnership between private business and government can lead to something that can benefit thousands of people and improve their quality of life," Knapp said.
ORNL, one of DOE's multiprogram research facilities, is managed by Lockheed Martin Energy Research Corporation.
Written by Courtney Wilson
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category: isotopes, technology