Vascular Grafts Solutions has announced receipt of marketing clearance from the US Food and Drug Administration (FDA) for the Viola, a new device for clampless proximal anastomosis in coronary artery bypass grafting (CABG).

Innovative Cardiovascular Solutions (ICS) has announced the success of its first European clinical cases using the next generation of the Emblok embolic protection system in patients undergoing transcatheter aortic valve implantation (TAVI). The procedures were performed by Federico De Marco at IRCCS Policlinico San Donato, Milan, Italy.

A US Food and Drug Administration (FDA) advisory panel has recommended against premarket approval of BD’s Lutonix 014 drug-coated balloon (DCB) for use in below-the-knee (BTK) arteries. In a meeting on 17 February, the majority of the FDA Cardiovascular Devices Panel concluded that the device was likely safe in BTK arteries, but not effective. The benefit-risk ratio also did not appear favourable for the Lutonix 014 DCB, it claimed.

A secondary analysis of the COAPT trial, which sought to account for differences in the findings of COAPT and the Mitra-FR trial in patients with secondary mitral regurgitation (MR), has concluded that a divergence between the two studies over inclusion criteria relating to “proportionate and disproportionate” MR did not predict outcomes within the COAPT trial.

After Shockwave Medical announced that its intravascular lithotripsy (IVL) technology received pre-market approval for the treatment of severely calcified coronary artery disease from the US Food and Drug Administration (FDA), Cardiovascular Newsspoke to Dean Kereiakes, president, The Christ Hospital Heart and Vascular Institute, professor of clinical medicine, The Ohio State University (Columbus, USA), and the co-principal investigator of the pivotal Disrupt CAD III study to discuss how IVL has the potential to revolutionise the treatment of problematic coronary calcium.

Urgent action is needed to address the growing burden of heart failure and the impact of COVID-19 in the UK, according to a report issued this week by the Alliance for Heart Failure.

Medtronic has voluntarily issued a global recall of its Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the device until further notice.

Caption Health has announced the publication of a study in JAMA Cardiology assessing its artificial intelligence (AI) guidance software for cardiac ultrasound examinations. The study was the basis for the February 2020 authorisation of Caption Guidance through the US Food and Drug Administration’s (FDA) de novopathway. The Caption AI platform, which includes Caption Guidance and Caption Interpretation, is an AI-guided medical imaging acquisition software.

Around 50% of patients who have been hospitalised with severe COVID-19 and have raised levels of troponin have heart damage, according to a study published in the European Heart Journal. The injury was detected by magnetic resonance imaging (MRI) scans at least a month after discharge and includes myocarditis, infarction, ischaemia and combinations of all three.

The German Institute for Hospital Remuneration (InEK) has renewed the new examination and treatment methods (NUB) Status 1 designation of VasQ external support (Laminate Medical Technologies) for 2021.

Cagent Vascular announced the results of its PRELUDE-BTK study at LINC 2021 (25–29 January, online). The PRELUDE-BTK study was a prospective, single-arm, multicentre feasibility study to show the safety and efficacy of serration angioplasty.

Twelve-month results from the PRESTIGE below-the-knee (BTK) study have been presented as a late-breaking trial at LINC 2021(The Leipzig Interventional Course; 25–29 January, online). The objective of this clinical investigation has been to evaluate safety and performance outcomes of SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions (TASC C and D) in patients with chronic limb-threatening ischaemia (CLTI).