Edwards Lifesciences (NYSE:EW) has notified providers of a higher-than-expected rate of injuries during deployment of its Cardioband mitral/tricuspid valve reconstruction system (TMVR).
Approximately 5.7% of patients treated with Cardioband suffered coronary artery injuries, most “as a result of direct interaction between the anchors of the Cardioband device and coronary arteries running adjacent to the valve annulus, identified either during anchor deployment or following band contraction,” the letter to physicians said. Other injuries are related to vessel remodeling with no direct anchor and vessel interaction, which may occur following contraction of the band, the letter added.
All events were identified during the Cardioband procedure and were successfully addressed through immediate medical intervention — with the majority of reported cases resolved using balloon dilation or stenting of the affected coronary artery, the letter said.
Edwards said it will “enhance existing warnings and instructions related to vessel injury avoidance” and that healthcare providers need not return unused devices. Patients who already have Cardioband implanted will not need further surgery, the letter added.
The company said that while it waits for approval of updated instructions for use (IFU) from notified bodies, those instructions have been incorporated in physician training materials. All users will be trained or retrained on this potential issue and preventive measures before using Cardioband, the company added. The letter includes updates to the relevant IFU sections.
Edwards advised physicians to take preventative measures to reduce likelihood of vessel damage, including:
- Consistently use a guidewire in the coronary artery in order to clearly visualize vessel throughout the procedure.
- Perform a coronary angiogram prior to first anchor deployment.
- Verify the proximity of the coronary artery to target anchor position throughout the procedure.
- Perform a final coronary angiogram before disconnecting delivery system from implant.
Cardioband is not available for sale in the United States.