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A thorough risk assessment of tumorigenic potential, including uncontrolled growth and malignant transformation, is mandatory before clinical translation

The applicant further stated that the Breakthrough Device designation applies to two clinical scenarios: a de novo system where a patient receives the Aveir TM Dual-Chamber Leadless Pacemaker, or an upgrade system where a patient already has a ventricular leadless pacemaker and is upgraded to the Aveir TM Dual-Chamber Leadless Pacemaker by receiving the Aveir TM AR Leadless Pacemaker

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Ros-atm-chk2 axis stabilizes hif-1 and promotes tumor angiogenesis in hypoxic microenvironment

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