FDA grants new valve-in-valve TAVR offering its breakthrough device designation

Pi-Cardia ShortCut TAVR device. According to Pi-Cardia, ShortCut is the first medical device of its kind; interventional cardiologists use it to split valve leaflets in patients who have been recommended for valve-in-valve TAVR and face a heightened coronary obstruction risk.

Interventional cardiologists use the ShortCut device to split valve leaflets in patients who have been recommended for valve-in-valve TAVR and face a heightened coronary obstruction risk. Image courtesy of Pi-Cardia. 

The new device was designed to help clinicians perform valve-in-valve TAVR on certain high-risk patients. One cardiologist familiar with the technology said it could be easily added to any preexisting TAVR workflow. 

Physician plaintiff: ‘I shouldn’t have to risk losing my license—or getting jail time’ over telehealth visits

telemedicine lawsuit new jersey

When policymakers eased rules and restrictions governing telemedicine in 2020, many patients and their doctors saw the change as one shiny silver lining in the very dark cloud that was the COVID-19 pandemic. Unfortunately for them, that period has passed.