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 cardiology, heart failure, electrophysiology, hypertension, structural heart disease, use of pharmaceuticals, and COVID-19.

World’s most populous country gains access to Medtronic’s newest TAVR valve
Medtronic developed the self-expanding Evolut FX+ TAVR system with improved coronary access in mind. The FDA-approved device has now officially launched in India.
New registry helps hospitals expand outpatient services for heart patients
The initiation of the ACC Ambulatory Surgical Center Registry comes at a time when hospitals are expanding their structural heart programs. The registry is providing valuable details about which patients should stay at the hospital and which can be treated in an outpatient setting.
FDA highlights risks of evaluating blood pressure with unauthorized medical devices
The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated.
Joysticks recalled after power wheelchairs move on their own, injuring a patient
The U.S. Food and Drug Administration announced a recall of Mo-Vis BVBA joysticks after a faulty firmware version was linked to the malfunction. Users will need to have their devices upgraded.
FDA approves nasal spray for edema associated with congestive heart failure
The newly approved intranasal loop diuretic can also be used to treat edema in patients with liver and kidney disease.

World’s most populous country gains access to Medtronic’s newest TAVR valve

Medtronic developed the self-expanding Evolut FX+ TAVR system with improved coronary access in mind. The FDA-approved device has now officially launched in India.

Joan Michaels, RN, director of the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Transcatheter Valve Therapies (TVT) and IMPACT congenital heart registries, said the addition of the ambulatory surgical center (ASC) registry comes at a time when hospitals are expanding structural heart programs and ASC's will likely play a growing role to help free up more hospital cath labs for the more complex cases.

New registry helps hospitals expand outpatient services for heart patients

The initiation of the ACC Ambulatory Surgical Center Registry comes at a time when hospitals are expanding their structural heart programs. The registry is providing valuable details about which patients should stay at the hospital and which can be treated in an outpatient setting.

FDA highlights risks of evaluating blood pressure with unauthorized medical devices

The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated.

Joysticks recalled after power wheelchairs move on their own, injuring a patient

The U.S. Food and Drug Administration announced a recall of Mo-Vis BVBA joysticks after a faulty firmware version was linked to the malfunction. Users will need to have their devices upgraded.

Corstasis Therapeutics bumetanide nasal spray Enbumyst

FDA approves nasal spray for edema associated with congestive heart failure

The newly approved intranasal loop diuretic can also be used to treat edema in patients with liver and kidney disease.

All medical device products in Europe need to obtain the Conformité Européenne mark (European Conformity, or CE mark) regulatory approval. This is based on minimal safety requirements and is needed to be sold in the EU.

Cardiologists lead charge for medical device approvals in Europe to be more rigorous

There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that.

Medline recalls surgical kits due to safety concern with Medtronic catheters

The FDA is warning the public that certain Medline surgical kits may contain catheters that have been linked to 41 customer complaints and three serious injuries.

COVID-induced neuroinflammation can last 2 years or longer, according to new PET data

These findings are important to consider with regard to patients’ long-term health, as chronic inflammation has been implicated in cognitive decline.