The FDA gave 510(k) clearance to the CareTaker wireless remote monitor for continuous heart rate and blood pressure measurements. The wearable device was deemed as good as the predicate NextFin monitor and perhaps even safer, given the lower coupling pressure delivered to the monitored finger.
Lariat XT, a device designed to remotely deliver sutures, also got 510(k) approval from the FDA. Note this is different from the Lariat+ device being tested for left atrial appendage closure in the ongoing aMAZE trial.
Below-the-knee peripheral artery disease can be effectively tackled with the Tack balloon angioplasty system, according to the TOBA-BTK study. Positive results (78.4% primary patency, 93.5% freedom from target lesion revascularization) were reported at the Society for Cardiovascular Angiography and Interventions annual meeting.
Recommendations for imaging of bioprosthetic heart valves were released in the European Heart Journal-Cardiovascular Imaging. Echocardiography was deemed the first-line approach for patients; other imaging modalities — cinefluoroscopy, cardiac computed tomography, cardiac magnetic resonance imaging (MRI), nuclear imaging — were also recommended as needed.
A “hybrid” approach to coronary chronic total occlusions in the cath lab can restore flow with less than 30% residual stenosis, a study suggests. Operators using antegrade/retrograde wire escalation and dissection re-entry techniques were successful in 90% of patients with high anatomical complexity.
For patients with heart failure, the FDA approved the Ipera ProMRI HF-T, a cardiac resynchronization defibrillator that is safe for use with MRI. This device is the latest from the ProMRI portfolio to be approved; last year the agency also gave a group of MRI-safe implantable cardioverter defibrillators the green light.
Beacon Tip catheters were voluntarily recalled after 30 reported cases of tip fracture and separation, according to an FDA alert. The root of the problem was polymer degradation.
For coronary bifurcation lesions, provisional T-stenting beats complex stenting techniques on 5-year mortality (3.8% versus 7.0%, P=0.04), a meta-analysis found.