Edwards Lifesciences has temporarily paused new enrolments in its active pivotal clinical trials of its transcatheter mitral and tricuspid therapies in response to ongoing COVID-19 pandemic. A press release reports that the company is coordinating closely with the trials’ clinical investigators at the relevant hospital. It adds that the decision to resume enrolments in the trials will be made in consultation with each investigator and hospital at the time when their clinicians’ and patients’ needs can be better served.
According to the press release, the company “continues to pursue its vision of transforming care for patients with mitral and tricuspid valvular disease by developing a portfolio of innovative therapies supported by a growing body of clinical evidence”.
Abiomed, makers of the Impella heart pump, has also postponed a clinical trial—the FDA STEMI-DTU randomised controlled trial. According to a press release, Abiomed plans to restart the study in approximately eight weeks when physicians and hospitals have the ability to enrol patients and record clinical metrics.