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FDA Probes Paclitaxel Devices; Patent Solution; Why Women Pass on the Cath Lab

The FDA is investigating the excess mortality risk linked to paclitaxel-coated balloons and stents in treating peripheral artery disease. The agency recommended monitoring patients who have received such devices, though it said it continues to believe that their benefits outweigh their risks. MedPage Today has the full story here.

Edwards Lifesciences said it is paying $180 million to Boston Scientific to settle all patent disputes related to transcatheter aortic valves, certain mitral valve repair devices, and left atrial appendage closure devices.

Philips announced that its Azurion 7 C20 image-guided therapy system now includes the FlexArm, which saves time during radial procedures by reducing table positioning movements.

The RAPID neuroimaging platform was FDA approved to help select for acute stroke patients with known occlusion of the internal carotid artery or proximal middle cerebral artery for a thrombectomy, iSchemaView announced.

A guide extension catheter enhanced the efficacy of drug-coated balloon angioplasty, according to a Japanese study. The catheter was associated with fewer 12-month adverse events, particularly target vessel revascularizations. (EuroIntervention)

Female cardiology fellows surveyed said that deterrents to their subspecialization in interventional cardiology include the physically demanding nature of the job, an “old boys’ club” culture, and the lack of female role models. (JACC: Cardiovascular Interventions)

Deferring revascularization on the basis of fractional flow reserve is riskier in acute coronary syndrome than in stable angina, showed one meta-analysis in Open Heart. It may be better to add intracoronary imaging into the mix to characterize plaques, the authors said, although this combined approach has not been validated.

The U.S. pivotal trial for Shockwave Medical’s coronary lithotripsy device is now underway. This device uses sonic pressure waves to fracture calcium in calcified coronary lesions before stenting. (Mass Device)

1969-12-31T19:00:00-0500

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Source: MedicalNewsToday.com