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Abbott Initiates New Intravascular Lithotripsy Clinical Trial to Improve Outcomes in Patients with Coronary Artery Disease

Summary by Denton Record-Chronicle
Coronary Artery Disease (CAD) is the most common heart disease and most frequent cause of death in the U.S., with over 20 million adults affected by this conditionAbbott's investigational Coronary Intravascular Lithotripsy (IVL) System offers a new potential treatment by…

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Denton Record-ChronicleDenton Record-Chronicle
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Abbott Initiates New Intravascular Lithotripsy Clinical Trial to Improve Outcomes in Patients with Coronary Artery Disease

Coronary Artery Disease (CAD) is the most common heart disease and most frequent cause of death in the U.S., with over 20 million adults affected by this conditionAbbott's investigational Coronary Intravascular Lithotripsy (IVL) System offers a new potential treatment by…

·Denton, United States
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Cardiovascular NewsCardiovascular News

Abbott to begin TECTONIC trial of IVL therapy prior to coronary stenting - Cardiovascular News

Abbott Logo (PRNewsFoto/Abbott) Abbott has announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its coronary intravascular lithotripsy (IVL) system to evaluate the treatment of severe calcification in coronary arteries prior to stenting. The TECTONIC CAD IVL clinical trial will enrol up to 335 people in 47 sites in the USA. Currently, physicians often use several therapy approaches t…

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cardiovascularbusiness.comcardiovascularbusiness.com

Abbott makes IVL move as FDA approves new clinical trial

Abbott has received an investigational device exemption from the FDA for a new clinical trial evaluating the safety and effectiveness of using its coronary IVL technology. The trial is expected to enroll up to 335 U.S. patients.

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Cardiac Interventions TodayCardiac Interventions Today

Abbott Initiates TECTONIC IDE Trial Evaluating New Coronary IVL Device - Cardiac Interventions Today

March 24, 2025—Abbott announced it received approval from the FDA to proceed with its TECTONIC coronary artery disease (CAD) intravascular lithotripsy (IVL) investigative device exemption trial. TECTONIC aims to evaluate the company’s new coronary IVL system in the treatment of severe calcification in coronary arteries before stenting. According to the company, the trial will enroll up to 335 patients across 47 sites in the United States. “For p…

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Denton Record-Chronicle broke the news in Denton, United States on Monday, March 24, 2025.
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