PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.

Medtronic plc’s winning streak continued this week with the announcement that the U.S. FDA had given its nod for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx drug-eluting stent (DES). The approval is based on results from the Onyx ONE Clear Study that evaluated about 1,500 complex HBR patients on one-month DAPT treated with Resolute Onyx.

Alucent Biomedical Inc., which is developing a restorative therapy for peripheral artery disease (PAD), completed a $35 million series B financing led by a multinational strategic investor. The funds will be used to complete clinical studies of the Alucent Natural Vascular Scaffolding (AlucentNVS) vessel restoration system with photoactivated linking, the company’s first product.

Sentiar Inc. received U.S. FDA clearance for its holographic guidance system, known as Commandep, for use in cardiac ablation procedures. The system allows electrophysiologists (EPs) to visualize 3D electroanatomic models in real-time, using augmented reality (AR), to seamlessly navigate invasive procedures. “The Commandep is intended for use as a medical imaging system that allows the review, analysis, communication and media interchange of multidimensional digital images,” Berk Tas, Sentiar’s CEO, told BioWorld.

PARIS – Miracor Medical SA secured a $28 million series E funding round for its Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) impulse system, intended for treating patients presenting with ST-Elevation Myocardial Infarction (STEMI). “This funding will be used to move the PiCSO clinical trial program forward, and to begin distributing our technology in Europe,” Olivier Delporte, CEO of Miracor, told BioWorld.

Boston Scientific Corp. reported the controlled launch of its Acurate Neo2 aortic valve system in Europe. The next-generation transcatheter aortic valve implantation (TAVI) technology extends the clinical performance of the original Acurate Neo platform and includes an expanded indication for patients with aortic stenosis.

The U.S. Centers for Medicare & Medicaid Services (CMS) recently proposed some changes to national coverage policies for left ventricular assist devices (LVADs) and artificial hearts, the latter of which would no longer be covered under a national coverage determination. The proposal to allow Medicare administrative contractors (MAC) to make coverage decisions for artificial hearts on a case-by-case basis clanged across both industry and medical societies, which cited data collection problems and inequalities in access as reasons the existing coverage policy should remain in place.

Scientists long have puzzled over what goes wrong in people with cardiovascular disease. Now, they have created a cellular and molecular map of the healthy human heart, with an eye toward preventing some of the 17.9 million deaths from cardiovascular disease that occur each year.