May 27, 2016 — A U.S. Food and Drug Administration (FDA) panel recommended approval of a transcatheter patent foramen ovale (PFO) occluder to prevent recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

The FDA’s Circulatory System Devices Panel met May 24 to discuss the merits of a premarket approval (PMA) application for St. Jude Medical’s Amplatzer PFO Occluder System. The panel voted to recommend approval to the FDA, but there were questions about the device and supporting data from several panel members. 



(Watch an  October 2019 update on this article with radial adoption rates nearing 50 percent in the U.S. in the VIDEO: Trends in Radial Access for Percutaneous Coronary Interventions)
 

 


Corsens Medical Ltd. announced it has successfully completed filing of a Pre-Marketing Notification (510(k)) with the U.S. Food and Drug Administration (FDA) for its Corsens Cardiac Monitor.

May 26, 2016 — Ligand Pharmaceuticals Inc. announced the acquisition of economic rights to multiple programs owned by CorMatrix. Ligand will pay $17.5 million and in return will receive a portion of revenue (synthetic royalty) from CorMatrix’s existing marketed products and will have the right to receive future synthetic royalties from potential future products.

The LifeBridge Health Cardiovascular Institute, Baltimore, has launched a pilot study to evaluate the potential benefits of a wireless heart monitoring system for patients with moderate to severe heart failure.

Cancer patients at the Carti Cancer Center, Little Rock, Ark., now have access to the latest innovation in diagnostic imaging with Toshiba America Medical Systems Inc.’s Infinix 4-D CT.


May 27, 2016 — Radiation exposure to cath lab staff and physicians has seen growing concern in recent years, as the prevalence of cancers and glaucoma has been observed to be high among interventional cardiologists. This has spurred research projects to help quantify the health risks of working in a cath lab and being exposed to ionizing radiation from the X-ray angiography systems.


Technavio’s latest report on the U.S. anticoagulants market provides an analysis on the most important trends expected to impact the market outlook from 2016-2020.

A new imaging system known as intravascular photoacoustic (IVPA) imaging that produces three-dimensional images of the insides of arteries has the potential to help doctors diagnose plaques on the brink of rupturing.

Subscribe Now