Clinical

This channel newsfeed includes clinical content on treating patients or the clinical implications in a variety of cardiac subspecialties and disease states. The channel includes news on cardiac surgery, interventional cardiologyheart failure, electrophysiologyhypertension, structural heart disease, use of pharmaceuticals, and COVID-19.   

FDA approves two studies examining TAVR devices

The FDA recently approved two investigational device exemption trials that will examine devices for patients undergoing transcatheter aortic valve replacement (TAVR).

Facilities meet CMS’ minimum standards for carotid artery stenting of high risk patients

Since the beginning of the year, eight facilities have met the Centers for Medicare & Medicaid Services’ (CMS’) minimum facility standards for performing carotid artery stenting for high risk patients.

IBHRE announces award winners

The International Board of Rhythm Heart Examiners (IBRHE) announced on March 22 that three people had received awards for volunteering their time and making significant contributions to the organization.

FDA proposes ban for most powdered gloves

After reviewing available information, the FDA announced a proposal on March 21 to ban most powdered gloves, including powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating surgeon’s gloves. The ban would not apply to powdered radiographic protection gloves or non-powdered surgeon gloves and non-powdered patient examination gloves.

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FDA advisory panel recommends against approval of the AngelMed Guardian system

An FDA advisory panel recommended against the approval of the AngelMed Guardian system, an implantable cardiac monitor, designed to detect rapid changes in the heart’s electrical signal caused by a coronary artery occlusion.

Oral anticoagulant prescriptions increase with higher stroke risk

An analysis of a quality improvement registry of patients with atrial fibrillation found that a one-point increase in the CHADS2 score or the CHA2DS2-VASc score was associated with an approximately 15 percent greater adjusted odds of being prescribed an oral anticoagulant.

FDA receives more than 9,000 malfunction reports with blood testing devices

Since 2002, the FDA has received more than 9,000 reports of malfunctions with the INRatio and INRatio2 blood testing devices, the New York Times reports. The devices are used to help manage patients who are taking warfarin. The newspaper said an analysis from the Public Citizen Health Research Group found that injuries associated with the INRatio devices are far higher than similar products. However, the FDA and INRatio’s developer (INRatio) have not publicly announced the apparent malfunction.

Boston Scientific, Mayo Clinic collaborate on medical device development

Boston Scientific and the Mayo Clinic announced on March 16 that they would continue to share intellectual property to develop medical devices that address unmet clinical needs in fields such as interventional cardiology, heart rhythm management, endoscopy, neuromodulation, urology and pelvic health.

Around the web

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.