Following the announcement by Edwards Lifesciences that its Pascal transcatheter valve repair system for treating tricuspid regurgitation (TR) received the European CE mark;

Ashley Young, Medical Device Analyst at GlobalData, a leading data and analytics company, offers her view on the news:

“This regulatory milestone comes at a poor time for the industry as COVID-19 case numbers continue to soar around the world. At the current time, hospital resources are almost entirely being shunted to deal with COVID-19 across Europe, especially in countries such as the US that are hard-hit by the pandemic. As such, most heart valve repair procedures, including the majority of transcatheter treatments for tricuspid regurgitation, are being delayed until hospital resources become more available.

“GlobalData predicts that the Pascal device will not be as successful at this time as it likely would have been otherwise. Since most physicians will delay transcatheter tricuspid valve repair procedures, hospitals may put off purchasing the Pascal device until these procedures are being carried out. GlobalData also predicts that Edwards Lifesciences will experience a surge in Pascal device purchases by hospitals after the COVID-19 pandemic ends, as hospitals work to catch up from the delayed procedures. However, any surge activity will be shared with the Pascal’s main competitor, Abbott’s TriClip device.”