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FDA grants new Elixir Medical Dynamx implant for BTK arterial disease its breakthrough device designation

Image courtesy of Elixir Medical.

Elixir Medical's DynamX BTK System is an implantable device that supports BTK vessels after PCI or other interventions.

Read more about FDA grants new implant for BTK arterial disease its breakthrough device designation

2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.

Internal medicine physicians spend a lot of time working with heart failure patients. A new commentary in JACC: Heart Failure explored the potential impact of providing IM trainees with special training so that they can deliver additional value.

Read more about A possible remedy for cardiology’s staffing shortages: heart failure internists

The U.S. Food and Drug Administration (FDA) has announced that Abiomed is recalling its instructions for certain Impella left-sided blood pumps due to significant safety concerns. New and revised instructions for use (IFU) have been sent to all affected customers.

Abiomed's Impella 5.5 with Smart Assist (pictured above) is one of the heart pumps included in the recall. Image courtesy of Abiomed.

More than 100 patients have been seriously injured as a result of a significant safety concern. The Impella devices can still be used, according to the recall, if customers refer to Abiomed's new and revised instructions for use.

Read more about FDA announces new recall impacting more than 66,000 Impella heart pumps after 49 deaths

COVID-19 vaccine vaccination myocarditis heart damage inflammation RSNA imaging radiology cardiology

Researchers explored data from more than 20 million adults for the new study, tracking both short- and long-term outcomes.

Read more about ‘Highly effective’: COVID-19 vaccines reduced risk of heart failure, other cardiovascular complications after infection

Aprocitentan, sold under the brand name Tryvio, is approved for patients with high blood pressure who are already taking other antihypertensive drugs.

Read more about FDA approves new hypertension drug months after Idorsia reacquired rights for $343M

Since the first U.S. deceased after circulatory death (DCD) heart transplant in late 2019, there has bee ongoing research to determine the best way to utilize this new source of donor hearts. Researchers at Stanford University School of Medicine recently published a study in JAMA Network Open about their use of beating heart transplant procedures. It was found to be safe and had additional benefits. By avoiding additional warm and cold ischemic periods it eliminated need for ECMO.

This new approach to transplanting deceased after circulatory death (DCD) hearts may offer significant benefits.

Read more about New DCD heart transplant technique could reduce risk of serious injury

Kumar Madassery, MD, director of peripheral vascular intervention and critical limb ischemia (CLI) program at Rush University Medical Center in Chicago, explains techniques and tools used to restore blood flow to the foot to help foot wounds heal and prevent amputation. He is part of a campaign to raise awareness through the PAD Pulse Alliance.

Kumar Madassery, MD, detailed some of the techniques and tools used to restore blood flow to the foot to help foot wounds heal and prevent amputation.

Read more about Interventional techniques can help limit amputations among CLI patients

Hoping to improve care for these patients, Hermann et al. turned to the ŌNŌ retrieval system, a catheter-delivered device cleared by the U.S. Food and Drug Administration in 2022. The device was developed by Ōnōcor, a U.S. healthcare startup with roots in the Penn Center for Innovation.

The ŌNŌ retrieval system pictured after removing an unstable Watchman FLX left atrial appendage occlusion device. Images courtesy of Hermann et al. and JACC: Clinical Electrophysiology.

A team of specialists in Houston made history, using the new-look device to treat three patients over the age of 80. The group shared its experience in JACC: Clinical Electrophysiology.

Read more about Cardiologists are first in world to remove unstable Watchman devices with FDA-cleared retrieval system

Time-restricted eating is popular in the United States, but new research suggests it may do more harm than good if taken to certain extremes.

Read more about Intermittent fasting may increase risk of death from heart attack, stroke

More than 5,000 U.S. physicians joined forces to launch the new group. They say they are focused on limiting private equity's involvement and influence in healthcare.

Read more about Doctors form new coalition focused on reducing private equity’s role in cardiology, other healthcare specialties