Best Vascular/Novoste Celebrates 25 Years of FDA-Approved Vascular Brachytherapy for Coronary Restenosis
Key Insights
November 2025 marks 25 years since the FDA approved vascular brachytherapy (search) for treating in-stent coronary artery restenosis (search), a condition that can re-narrow arteries after stent placement.
The breakthrough began with pioneering research in 1994 by Dr. Paul Teirstein at Scripps Clinic and Dr. Ron Waksman at Emory University, using Iridium-192 (search) seeds in nylon ribbons.
Both the Novoste Beta-Cath System (search) and Cordis's Iridium-192 (search)-based therapy received FDA approval on November 3, 2000, making vascular brachytherapy (search) officially available for clinical use.
November 2025 marks a significant milestone in cardiovascular medicine as the medical community celebrates 25 years since the U.S. Food and Drug Administration approved vascular brachytherapy (search) (VBT) for treating in-stent coronary artery restenosis (search). This condition, which can cause arteries to re-narrow after stent placement, represented a major clinical challenge that vascular brachytherapy helped address.
Pioneering Research Foundation
The journey toward FDA approval began more than three decades ago when researchers first explored how radiation could safely improve outcomes for heart patients. In 1994, Dr. Paul Teirstein of Scripps Clinic in La Jolla, California, partnered with Best Medical International (search) (BMI) to launch the first randomized, double-blind Phase 1 human clinical trial using Iridium-192 (search) seeds in nylon ribbons. Simultaneously, Dr. Ron Waksman at Emory University in Atlanta, Georgia, conducted complementary animal studies using the same BMI technology.
The early research produced promising results, which were first shared publicly at the inaugural VBT meeting hosted by Dr. Waksman, BMI's Best Cure division, and Emory University in January 1996 at the JW Marriott Hotel in Atlanta.
Clinical Development and Industry Collaboration
Following the initial promising results, Novoste Corporation (search), based in Norcross, Georgia, joined the development effort. Working closely with Dr. Waksman, Novoste began human trials using BMI's Iridium-192 (search) technology as part of the Beta-Cath clinical program. During 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 research efforts culminated in a landmark regulatory achievement on November 3, 2000, when both the Novoste Beta-Cath System (search) and Cordis's Iridium-192 (search)-based therapy received FDA approval for treating in-stent restenosis, officially making vascular brachytherapy (search) available for clinical use in the United States.
Continued Innovation and Global Leadership
In 2006, Best Vascular, Inc., an affiliate of Best Medical International (search), acquired the Beta-Cath assets from Novoste Corporation (search) and continued operations at the same Norcross facility under the name Best Vascular/Novoste (search). Nearly two decades later, Best Vascular/Novoste remains a global leader in vascular brachytherapy (search) technology.
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 (search) is inviting clinicians, researchers, and partners to collaborate on new VBT advancements and to contribute to an upcoming book on vascular brachytherapy (search), scheduled for publication in 2026.
Corporate Background
Best Vascular/Novoste (search) operates as part of TeamBest Global Companies (search), a multinational medical company founded in 1977 in Springfield, Virginia. TeamBest includes over a dozen companies offering complementary products and services for brachytherapy, health physics, medical physics, radiation therapy, blood irradiation, vascular brachytherapy (search), imaging, medical particle acceleration, cyclotrons, and proton-to-carbon heavy ion therapy systems. The company employs hundreds of talented engineers and scientists, offering thousands of products and services across North America, Europe, Latin America, Africa, the Middle East, and Asia.