Abbott receives FDA approval to begin Phase 3 trial of its Intravascular Lithotripsy system aimed at improving outcomes for severe coronary calcification.
New Clinical Trial Targets Heart Disease Treatment Gap
Abbott announced the initiation of the TECTONIC clinical trial to evaluate the Coronary Intravascular Lithotripsy (IVL) system in patients with heavily calcified coronary arteries undergoing stent placement. This innovative technology uses high-energy sound waves to fracture calcium deposits within the arterial wall, potentially enhancing vessel expansion and stent efficacy.
The FDA’s Investigational Device Exemption (IDE) approval enables enrollment of up to 335 patients across 47 US sites. Coronary artery disease remains the leading cause of death in the United States, and improving treatment of calcified lesions is a significant clinical need.
Advantages Over Existing Treatments
IVL offers a less invasive and more precise alternative to traditional therapies such as cutting balloons and atherectomy. Abbott highlights that IVL’s mechanism minimizes vessel trauma and improves stent placement outcomes, potentially reducing procedural complications and improving long-term patient prognosis.
Trial Design and Future Outlook
The randomized, controlled TECTONIC study will measure procedural success, safety endpoints, and patient health outcomes through 12 months post-procedure. Abbott aims to leverage successful trial data for regulatory approval and commercial launch.
This trial underscores Abbott’s strategic commitment to advancing cardiovascular interventions through device innovation, addressing critical unmet medical needs.
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