Boston Scientific Corp. presented late-breaking data at EuroPCR 2021 demonstrating positive procedural performance for its Acurate Neo2 aortic valve system, including low rates of paravalvular leakage (PVL) and permanent pacemaker implementation (PPI). The findings are good news, following the older Acurate Neo’s failure to demonstrate noninferiority to Medtronic plc’s Evolut R in the so-called SCOPE II study.

PARIS – Tecmoled SAS has just completed the initial testing phase for its wireless oximeter. A prototype has been tested over the past four months on 30 healthy subjects, aged 2 to 70 years, to measure oxygen saturation (SpO₂), heart rate and body temperature.

While the founder of Woebot Health says that the app is not intended to replace human therapists, for the majority of the world who cannot locate an available psychologist or afford one once found, Woebot aims to offer a “radically accessible” option for mental health care.

Percutaneously implanted devices designed to seal off the left atrial appendage (LAA) have been around for some time, but a recent study of surgical closure of the appendage might have a beneficial effect on sales of these devices despite that the study did not deal directly with these devices. The results were compelling enough to provoke a halt to the study before all patients had reached the projected term of follow-up, and at least one observer said it may be time to study whether more routine use of devices for percutaneous LAA closure is indicated.

Two-year results from the Evolut Low Risk Trial show Medtronic plc’s Evolut transcatheter aortic valve replacement (TAVR) is noninferior to open-heart surgery in younger, healthier aortic stenosis patients. Moreover, the Evolut cohort fared better on certain critical events. Specifically, two-year rates of all-cause mortality or disabling stroke were 4.3% for TAVR patients vs. 6.3% for those undergoing surgical aortic valve repair (SAVR).

Across the world, rates of depression have reached alarming new heights as a result of the grief, uncertainty and isolation experienced through the pandemic. Despite the high prevalence of depression, its treatment remains a hit-or-miss affair. Up to two-thirds of patients fail to respond to the first antidepressant prescribed and many of them never return to try another. Tel Aviv-based Taliaz Ltd. has developed an artificial intelligence-driven tool to help psychiatrists and other prescribers get it right the first time.

Acutus Medical Inc. appears to have solved one of the more vexing problems in cardiology, the sheer persistence of persistent atrial fibrillation despite treatment. In a study recently published in Heart Rhythm, the Carlsbad, Calif.-based company demonstrated that 73% of patients undergoing ablation using the new pulmonary vein isolation plus core-to-boundary guided approach experienced acute termination of AF after one procedure, compared to 10% of patients undergoing ablation with the traditional posterior wall isolation approach.

Medtronic plc reported positive interim results on the first 171 patients implanted with Evolut transaortic valve replacement (TAVR) devices in its OPTIMIZE PRO clinical trial. The postmarket, prospective, multicenter study is assessing procedural outcomes, including pacemaker rate, associated with in-procedure techniques and post-procedure TAVR care pathways when using the self-expanding, supra-annular Evolut Pro and Pro+ TAVR systems in patients with symptomatic severe aortic stenosis.

TORONTO – Perimeter Medical Imaging Inc. has been awarded an FDA breakthrough device designation for a machine learning medical platform it said drives ultra-high-resolution, real-time imaging of breast cancer. Data collected from multiple pathology labs in Texas this past year were fed through the optical coherence tomography (OCT) imaging system which now is at the stage where its Imgassist artificial intelligence (AI)-based algorithms can be tested.

Atheart Medical Inc. came on the market with splash, simultaneously announcing the company’s formation and its launch of a U.S. investigational device exemption (IDE) trial for the Resept ASD occluder, a device designed to close atrial septal defects. Resept features a metal-free, bioresorbable frame to reduce the risks associated with the long-term presence of metal in the heart.