atHeart Medical has announced that it has received US Food and Drug Administration (FDA) approval for the start of the second phase of its ASCENT ASD US investigational device exemption (IDE) pivotal trial, evaluating the safety and efficacy of the reSept atrial septal defect (ASD) occluder.

CroíValve has raised a Series A round to fund a feasibility clinical study with its Duo Coaptation Valve system, a novel treatment for tricuspid regurgitation (TR).

Royal Philips today announced physicians will now have access to advanced new 3D image guidance capabilities through its image-guided therapy mobile C-arm system—Zenition. The system will deliver enhanced clinical accuracy and efficiency, according to Philips, and aims to improve outcomes for patients undergoing endovascular treatment. The company has signed a strategic partnership agreement with Cydar, a UK based provider of cloud-based procedure maps software to plan and guide surgery in real time.

The American Association for Thoracic Surgery (AATS) and The Society of Thoracic Surgeons (STS) have opted not to endorse new joint guidelines for coronary artery revascularisation, issued in late 2021 by three major cardiology bodies, citing that the guidelines do not reflect their interpretation of the best treatment for patients with ischaemic heart disease.

Terumo Medical Corporation has welcomed the publication of updated guidelines from the American College of Cardiology (ACC), American Heart Association (AHA) and the Society for Cardiovascular Angiography and Interventions (SCAI) which upgrade the recommendation for radial access in patients undergoing percutaneous coronary intervention (PCI).

Robocath has announced the conclusion of its R-Evolution clinical study in Europe, which was aimed at assessing the safety and efficacy of the R-One robotic assistance platform for percutaneous coronary intervention (PCI) procedures.

Regulators in three countries have granted approvals to Impella surgical products. In the USA, the Food and Drug Administration (FDA) has granted an Early Feasibility Study (EFS) Investigational Device Exemption (IDE) to Impella BTR (Bridge-to-Recovery). In Asia, Impella 5.5 with SmartAssist has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Hong Kong’s Medical Device Division (MDD).

Medtronic has announced that the National Medical Products Administration (NMPA) has approved the CoreValve Evolut PRO transcatheter aortic valve implantation (TAVI) system for the treatment of severe aortic stenosis (AS) for symptomatic patients in China who are at high or extreme risk for open heart surgery.

Neovasc has announced enrolment of the first patient in the COSIRA-II clinical trial.

Biomodex and the Montreal Heart Institute (MHI, Montreal, Canada) are partnering to develop a new training solution to help cardiologists rehearse and train for complex valve-in-valve procedures.

Endotronix has announced that the US Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor, shifting the design from a randomised control study to a single-arm study.

Vesalio recently announced the start of enrolment in its NATURE study using enVast, the company’s first thrombectomy system for patients presenting with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention.