August 14, 2019 — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA, its sirolimus drug coated balloon (DCB) catheter, for the treatment of peripheral artery disease (PAD) in below-the-knee (BTK) applications.
Visit WebsiteAugust 14, 2019 — Ancora Heart Inc. announced the first patient was enrolled in the CorCinch EU study, a European multi-center clinical evaluation of the AccuCinch Ventricular Repair System as a treatment for patients with reduced ejection fraction systolic heart failure (HFrEF).
Visit WebsiteAs we usher in a new era for treating patients with aortic stenosis, we have been reflecting on the evolution of the technology used for transcatheter aortic valve replacement (TAVR) and the evolution of our collaborative process as a team over years as a center in the PARTNER 3 clinical trial. PARTNER 3, which this year showed low-risk patients fared as well or better with TAVR as they did with surgery.
Visit WebsiteAugust 6, 2019 — Cardiovascular Systems Inc. (CSI) has acquired the Wirion Embolic Protection System and related assets from Gardia Medical Ltd., a wholly owned Israeli subsidiary of Allium Medical Solutions Ltd.
Visit WebsiteAugust 6, 2019 — When used with a common heart scan, machine learning, a type of artificial intelligence (AI), does better than conventional risk models at predicting heart attacks and other cardiac events, according to a study published in the journal Radiology.
Visit WebsiteNew technologies have been developed that may replace the traditional pressure wires and adenosine to assess the fractional flow reserve (FFR). This includes image-derived FFR, such as noninvasive computed tomography imaging derived FFR (FFR-CT), and X-ray angiography derived FFR (FFR-angio) that can be performed while the patient is on the table in the cath lab.
Visit WebsiteGuidewire engineering has become more advanced over the past decade as interventional cardiologists have advanced their trade to tackle much more complex lesions, including chronic total occlusions (CTO).
Visit WebsiteAugust 1, 2019 — Less-invasive procedures to open severely clogged leg arteries were as good at helping people survive and avoid amputation as more invasive open surgeries, according to a new study. The results were reported in Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal.
Visit WebsiteJuly 31, 2019 — Researchers found anti-inflammatory drug therapies used to treat moderate to severe psoriasis can significantly reduce coronary inflammation in patients with the chronic skin condition.
Visit WebsiteThe U.S. Food and Drug Administration announced Maquet/Datascope is recalling allintra-aortic balloon pumps (IABP) due to reports of the batteries failing to hold a charge, stopping unexpectedly and having a shortened run-time. This may cause the device to stop working when being operated by battery only. The FDA issued a recall notice that said if a patient requires life-supporting therapy with an IABP and the device does not work or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including death.
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