Concept Medical Inc. (CMI) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for MagicTouch, its sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR).

Abiomed announced that, on April 26, the U.S. Food and Drug Administration (FDA) approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial. The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive delayed reperfusion after 30 minutes of left ventricular unloading with the Impella CP. The other half will receive immediate reperfusion, the current standard of care.

A new document compiled by four cardiac imaging professional societies provides a resource to guide clinicians in best practices for assessing valvular regurgitation following catheter-based repair or replacement of a valve. The document, available in full here, supplements the previously published guideline Recommendations for Evaluation of Prosthetic Valves with Echocardiography and Doppler Ultrasound.

Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. The firm has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the femoral and iliac veins; additional procedures to retrieve the fragments; permanent patient disability; pulmonary embolism; stroke; damage to other organs; or death. One serious injury was reported in which an infant underwent an invasive, but successful surgical procedure to retrieve a detached balloon. There were no deaths reported.