The Priority Review

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Abbott

3 stories

Stories

  1. Clinical trials

    Abbott reports strong 30-day outcomes in TECTONIC IVL study

    The TECTONIC CAD IVL IDE Study enrolled 335 patients and met its primary safety endpoint with a 30-day target lesion failure rate of 0.3%. The study also achieved a primary effectiveness endpoint with procedural success in 97% of patients.

  2. Clinical trials

    Abbott initiates CROWN-MV pivotal trial for Cephea device

    Abbott has started the CROWN-MV study, a prospective pivotal trial that will enroll up to 585 patients with symptomatic mitral valve disease in the U.S., Canada and Europe. The trial will evaluate the safety and effectiveness of the investigational Cephea Mitral Valve System, a catheter-based replacement option for patients not candidates for surgery or transcatheter repair.

  3. Policy

    Abbott launches whole-genome sequencing Oncodetect MRD test

    Abbott announced the commercial availability of its next-generation Oncodetect MRD test, a personalized, tumor-informed, whole-genome sequencing test that tracks up to 5,000 patient-specific variants with a limit of detection below one part per million. The company said the test could be used for patients with solid tumors.