Five-year follow-up results from the Gore REDUCE study, assessing the Gore Cardioform or Helex septal occluder versus antiplatelet therapy in long-term recurrent stroke prevention, have been published in the March 2021 issue of The New England Journal of Medicine (NEJM). The results highlight the benefits of patent foramen ovale (PFO) closure, Gore said in a press release.

Data from an international registry of patients undergoing a procedure known as BASILICA, which is intended to prevent coronary obstruction during transcatheter aortic valve implantation (TAVI), show that the technique is safe, with low stroke and death rates, and feasible, with high procedure success and low coronary artery obstruction rate.

Following consultation with its notified body, MEDCERT GmbH, Abiomed is introducing the single access procedure with Impella CP introducer sheaths for the treatment of heart disease in Europe.

ControlRad has announced US Food and Drug Administration (FDA) 510(k) clearance to market ControlRad Select, a technology that utilises proprietary semi-transparent filters, a user-interface tablet, and image processing algorithms to reduce radiation exposure during fluoroscopically guided procedures.

A global collaboration between international heart failure bodies seeks to standardise the language and practices around the definition and classification of heart failure around the globe.

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.