Boston Scientific Corp. resumed enrollment in the AVANT GUARD trial of the Farapulse pulse field ablation (PFA) system after a pause reported in October “to assess a few unanticipated observations.” The trial aims to expand the indications for the market-leading PFA system to include a new population, drug-naïve patients with persistent atrial fibrillation.

While the size of the market is enormous, drug development and treatments for women’s health care still lag behind what is offered for men. There has been a renaissance in the past few years, however, led by investors and companies that have wrestled with determining exactly what encompasses women’s health and how to meet its challenges.

Boston Scientific Corp. signed a definitive agreement to acquire Cortex Inc., from Ajax Health Inc. to develop an integrated mapping and ablation solution for cardiac arrhythmias. Cortex’s Optimap system employs a basket catheter and algorithm to identify active sources for atrial fibrillation beyond the pulmonary veins on which most mapping and ablation technology currently focus.

415 Capital Management GmbH launched its second fund as it looks to raise €150 million (US$165 million) to invest in companies developing medical technologies to address cardiovascular and neurovascular diseases.

Two recent trials in cardiovascular disease took critical steps toward addressing ongoing and deadly disparities in cardiac care by focusing entirely on women.

The first year of data from the TRISCEND II study of the Evoque tricuspid valve by Edwards Lifesciences Corp. confirm the notion that reduced regurgitation has a big impact on patient well-being. While one-year data support the device’s safety, cardiovascular mortality at one year does not seem to decisively favor the device over medical management.

The ACURATE study of the Accurate neo2 TAVR device by Boston Scientific Corp., failed to demonstrate the device is non-inferior to established devices, but the COVID-19 pandemic threw up some roadblocks.

The contest between the two main classes of antiproliferatives for circulatory system use continues as seen in a presentation at this year’s Transcatheter Cardiovascular Therapeutics.

Atherectomy devices play a key role in dealing with calcified coronary arteries. But a study presented at this year’s Transcatheter Cardiovascular Therapeutics demonstrates that angioplasty balloons made a lot of headway in this clinical area, potentially pushing atherectomy devices into the fringes of routine practice.

Some studies suggest a need for cardiologists to rethink their approach to device implant. However, the TAVR UNLOAD study failed to demonstrate a statistically significant difference between device implant and medical management for patients with aortic stenosis and low left ventricular ejection fraction.