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.

The U.S. FDA’s approval of the Abbott Laboratories Triclip was predicated on a data set comprised of 350 patients, but an additional bolus of data seems to reinforce the rationale for the FDA approval, including improvements in quality of life.

Shockwave Medical, a unit of New Brunswick, N.J.-based Johnson & Johnson Medtech, completed enrollment in the first prospective all-female study of percutaneous coronary intervention in complex disease. The real-world, all-comers trial will evaluate the benefits of coronary intravascular lithotripsy in female patients with calcified lesions.

Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition.

Bayer AG has entered into an exclusive licensing agreement with Dewpoint Therapeutics Inc. for a heart disease program to treat dilated cardiomyopathy (DCM) patients characterized by specific mutations.

Researchers from Affinia Therapeutics Inc. have described the development and preclinical evaluation of a new AAV-based gene therapy, designed using a novel cardiotropic capsid, for the potential treatment of MYBPC3-associated hypertrophic cardiomyopathy (HCM).

Boston Scientific Corp. posted another eye-popping quarterly report, led by a 177% year-over-year increase in its electrophysiology business to $527 million, which exceeded consensus expectations by $99 million. That stunning EP growth follows 125% growth in the second quarter and 70% in the first quarter, all largely attributed to the Farapulse pulsed field ablation system, which achieved unprecedented adoption rates.

Researchers from the University of Maryland in collaboration with the National Institutes of Health (NIH) and Duke University have identified angiopoietin-2 (Ang2) as a targetable protein to reverse cardiovascular dysfunction in Hutchinson-Gilford progeria syndrome (HGPS).