Two members of the Center for Medical Device Evaluation had simultaneous publications in connection with their presentations at the 2026 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, CA this past weekend.
Dr. Eric Secemsky's late-breaker on the 30-day results of the TECTONIC CAD IVL IDE study has been published in JACC: Cardiovascular Interventions.
The TECTONIC investigational device exemption (IDE) study examines the safety and efficacy of Abbott’s SonicForce coronary intravascular lithotripsy (IVL) system in the treatment of coronary artery disease (CAD).
🔍Key findings include:
- The SonicForce IVL system met both prespecified coprimary safety and effectiveness endpoints
- Low 30-day target lesion failure and high procedural success were noted in patients with severely calcified de novo coronary lesions
📄 Read the full publication: https://www.jacc.org/doi/10.1016/j.jcin.2026.10.002
Eric A. Secemsky, Kate Kearny, et al
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Dr. Matthew Herzig's novel observational study on the real-world efficacy of the ceiling-mounted Rampart Guardian system, first presented as a TCT abstract, has been published in JSCAI.
Dr. Herzig’s study investigates the effectiveness of the Rampart Guardian system in reducing radiation exposure to endovascular operators.
🔍Key findings include:
- In 29.6% of procedures, operator radiation exposure was below the limit of detection (<1 μSv) of dosimeters used in the study
- An operator performing a median of 500 coronary procedures/year would receive 0.5 mSv of exposure, 2.5% of the recommended max annual exposure per consensus guidelines
📄 Read the full publication here: Observed Lead-Free Radiation Exposure With the Rampart Guardian System During Endovascular Procedures - Journal of the Society for Cardiovascular Angiography & Interventions
Matthew S. Herzig ∙ Ajar Kochar ∙ James B. Hermiller ∙ Rhian E. Davies ∙ William J. Nicholson ∙ Hibiki Orui ∙ Eric A. Secemsky
