Best Vascular/Novoste Marks 25 Years Since FDA Approval of Vascular Brachytherapy
Celebrating a groundbreaking milestone in heart health innovation – Washington, DC, USA – (PRESS RANGER) – November 6, 2025
This month marks a major milestone in cardiovascular medicine: 25 years since the U.S. Food and Drug Administration (FDA) approved vascular brachytherapy (VBT) for treating in-stent coronary artery restenosis — a condition that can re-narrow arteries after stent placement.
It all began more than three decades ago, when pioneering researchers began exploring how radiation could safely be used to improve outcomes for heart patients. In 1994, Dr. Paul Teirstein of Scripps Clinic in La Jolla, California, in partnership with Best Medical International (BMI), launched the first randomized, double-blind Phase 1 human clinical trial using Iridium-192 seeds in nylon ribbons. Around the same time, Dr. Ron Waksman at Emory University in Atlanta, Georgia, was conducting complementary animal studies using the same BMI technology.
The early research produced promising results. These findings were first shared publicly at the inaugural VBT meeting — hosted by Dr. Waksman, BMI’s Best Cure division, and Emory University — held in January 1996 at the JW Marriott Hotel in Atlanta.
Soon after, Novoste Corporation, based in Norcross, Georgia, joined the effort. Working closely with Dr. Waksman, Novoste began human trials using BMI’s Iridium-192 technology as part of the Beta-Cath clinical program. Around the same period, Cordis Corporation (then a Johnson & Johnson company) also conducted successful Phase II clinical studies using BMI’s Iridium-192 seeds.
These combined efforts culminated in a landmark moment on November 3, 2000, when both the Novoste Beta-Cath System and Cordis’s Iridium-192–based therapy received FDA approval for treating in-stent restenosis—making vascular brachytherapy officially available for clinical use in the United States.
In 2006, Best Vascular, Inc., an affiliate of Best Medical International, acquired the Beta-Cath assets from Novoste Corporation and continued operations at the same Norcross facility under the name Best Vascular/Novoste.
Today, nearly two decades later, Best Vascular/Novoste remains a global leader in vascular brachytherapy. The company continues to support ongoing use of VBT and is expanding its applications for future generations of patients. As part of this effort, Best Vascular/Novoste invites clinicians, researchers, and partners to collaborate on new VBT advancements and to contribute to an upcoming book on vascular brachytherapy, scheduled for publication in 2026.
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