Even though Cytokinetics Inc. received applause for testing its heart failure drug, omecamtiv mecarbil, in the second largest global heart disease clinical trial ever, the drug didn’t get a standing ovation from the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Dec. 13.

What could be Cytokinetics Inc.’s first approved drug will take center stage Dec. 13 at a meeting of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee. But judging from the FDA’s briefing document for the meeting, the spotlight on the heart failure drug, omecamtiv mecarbil, could be harsh.

Cerenovus Inc. reported primary results from the real-world EXCELLENT Registry showing positive outcomes with its Embotrap revascularization devices in the removal of stroke-inducing blood clots. Patients enrolled in the registry were treated with either the Embotrap II or Embotrap III devices as a first line therapy to treat ischemic stroke.

Heart Test Laboratories Inc., doing business as Heartsciences, said an independent study shows its Myovista electrocardiogram (ECG) machine learning model could be a cost-effective way to predict and stratify cardiac risk.

Medtronic plc reported six-month results from the full cohort of its Spyral HTN-ON MED study, showing a statistically significant reduction in office-based blood pressure, a key secondary endpoint. However, the trial missed its primary efficacy endpoint of a reduction in 24-hour systolic blood pressure, compared with a sham procedure.

Synaptive Medical Inc. and Panaxium SAS have inked a deal to bring high-resolution, real-time, artificial intelligence (AI)-assisted cortical mapping to neurosurgeons. Under the collaboration, Synaptive’s Modus V robotic exoscope technology will be integrated with Panaxium’s ultra-flexible iontronic electrocorticography (ECoG) platform.

U.S. lawmakers concerned about unconfirmed clinical benefit of drugs with accelerated approval got more fodder for their arguments in a new report from the Department of Health and Human Services Office of Inspector General (OIG). According to that report, which was released Sept. 29, Medicare and Medicaid have spent more than $18 billion over the past few years covering 18 drugs granted accelerated approval that haven’t completed their confirmatory trials even though the trial completion dates have passed.

Boston Scientific Corp. and Abbott Laboratories continue to parry over clinical trials comparing the latter’s Amplatzer Amulet with Boston Scientific’s Watchman in sealing the heart’s left atrial appendage (LAA) to prevent ischemic stroke in patients with atrial fibrillation (Afib). In one of five presentations at the 34th Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston in mid-September, Abbott said device-related thrombosis or peri-device leak more frequently preceded strokes in patients with Watchman compared to those with Abbott’s Amplatzer Amulet device.

Transcatheter aortic valve replacement (TAVR) continues to grow, so it is little surprise that the 2022 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting featured multiple presentations about TAVR-related devices and outcomes. The American College of Cardiology/American Heart Association’s latest guidelines recommends TAVR for patients over age 80 and surgery for those under age 65. Those in the middle can go either way, depending on comorbidities and patient preferences.