Best Vascular/Novoste Celebrates 24th Anniversary of Vascular Brachytherapy Approval & Use of by US FDA

WASHINGTON--(BUSINESS WIRE)--It’s been over 30 years since the first vascular brachytherapy (VBT) animal experiments and human clinical trials were performed and 24 years since the approval of VBT for human clinical use for the treatment of in-stent coronary artery restenosis by the US FDA on November 3, 2000.

Dr. Paul Teirstein, at Scripps Clinic in La Jolla, California, in collaboration with Virginia-based Best Medical International (BMI), began the first randomized, double-blind human clinical trials Phase 1 study using Iridium-192 seeds in nylon ribbons starting in 1994.

At approximately the same time, Dr. Ron Waksman, at Emory University in Atlanta, Georgia, in collaboration with BMI, was conducting animal experiments using Iridium-192 seeds in nylon ribbons.

All the initial animal experiments and human clinical studies were conducted using BMI Iridium-192 seeds in nylon ribbons. The first Phase 1 study’s successful clinical results were published at the first VBT meeting, hosted by Dr. Ron Waksman and Emory University, in January 1996 at the JW Marriott Hotel in Atlanta, Georgia.

Subsequently, the Novoste Corporation, located in Norcross, Georgia—which started conducting BetaCath clinical trials—began to conduct human clinical trials with Dr. Ron Waksman's assistance, for in-stent coronary artery restenosis and like the Scripps Clinic Phase 1 clinical trials, used Iridium-192 seeds in nylon ribbons manufactured and supplied by BMI.

The human clinical trials Phase II studies by Cordis Corporation (located in Miami Lakes, Florida and was a J&J company at the time) using BMI Iridium-192 seeds in nylon ribbons and by Novoste using Beta-Cath Device, were approved for in-stent coronary artery restenosis treatment by the US FDA at the same time—November 3, 2000.

BMI, using its affiliated company Best Vascular, Inc., purchased the Beta-Cath assets of Novoste Corporation on March 10, 2006, and continued operating the same Novoste manufacturing facilities but now under the name Best Vascular, Inc./Novoste.

More than 18 years later, Best Vascular/Novoste continues to support and plans to expand the clinical uses of VBT. The company is currently seeking for its customers to help develop future applications of VBT and contribute to a book on VBT, set to be published in 2025.