The FDA gave the Impella heart pumps the green light for treating cardiogenic shock, making these the only percutaneous temporary ventricular support devices approved for this indication.
Also getting a thumbs up from the FDA was the Micra Transcatheter Pacing System. “As the first leadless pacemaker, Micra offers a new option for patients considering a single chamber pacemaker device, which may help prevent problems associated with the wired leads,” William Maisel, MD, MPH, of the FDA, said in a press release.
But it’s a Class I recall for the Guardian II Hemostasis Valve for preventing blood loss during catheterization. Device maker Vascular Solutions cited a defect in the low-pressure seal that would potentially allow for air embolism.
Transcatheter aortic valve replacement (TAVR) for a patient at risk of contrast-induced acute kidney injury? There could be a device for that. The RenalGuard System may prevent nephropathy by inducing high urine rates, a small study suggested.
Fears of terrorist attacks in Europe have led to the cancellation of EuroPRevent. The European Society of Cardiology had originally slated the conference for May 4-7 in Istanbul.
Two predictors for mortality after PCI of the unprotected left main emerged in a population-based registry: pre-procedural ventilation (for patients with non-ST-segment elevation acute coronary syndrome and ST-segment elevation myocardial infarction [STEMI] without cardiogenic shock) and TIMI flow (for those with STEMI coupled with cardiogenic shock).
A non-invasive measurement of fractional flow reserve worked well as a tool when selecting intermediate stenosis patients for catheterization. The technology takes advantage of coronary CT, in lieu of invasive coronary angiography.