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.

Shockwave Medical launches new IVL catheter for challenging lesions in Europe
The balloon-free catheter, which already had a successful launch in the United States, has been associated with positive outcomes and the ability to reach certain lesions more accurately than balloon-based IVL platforms.
FDA clears Apple Watch algorithm for detecting hypertension
The FDA’s decision arrived just days after Apple announced the new feature. "This tool empowers patients and clinicians to work together, putting prevention at the center of care," one cardiologist told Cardiovascular Business.
Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries
Safety concerns with certain Boston Scientific leads have resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August.
Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately
The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.
Cardiologist sues hospital after he was allegedly let go for sharing safety concerns
The veteran interventional cardiologist claims he was pushed out after repeatedly asking for more coverage from cardiothoracic surgeons in addition to other improvements. The hospital, meanwhile, described the lawsuit as a “collection of false allegations."

Royal Philips has received U.S. Food and Drug Administration (FDA) approval for its new 160-cm LumiGuide endovascular navigation wire, which uses the company’s popular Fiber Optic RealShape (FORS) technology to deliver real-time 3D visualization without the use of fluoroscopy.

FDA approves longer LumiGuide 3D navigation wire from Philips

The newly approved device comes in at 160 cm. Like the shorter LumiGuide device from Philips, it was designed to deliver real-time 3D visualization with light instead of X-rays.

Merit Medical to purchase Cook Medical’s lead management portfolio for $210M

Two medical device companies have announced a transaction that could shake up the U.S. electrophysiology market.

Harlan Krumholz, MD, SM, editor-in-chief of the Journal of the American College of Cardiology (JACC), and a cardiologist and the Harold H. Hines, Jr. Professor of Medicine at the Yale school Medicine, explains some of the key technology advances he is watching across cardiology.

JACC editor excited by progress during a 'very important moment' for cardiology

Harlan Krumholz, MD, editor-in-chief of the Journal of the American College of Cardiology, explains some of the key technology and treatment trends he has his eyes on.

MRI findings linked to cognitive issues in patients with long COVID 2 years post-infection

The CDC estimates that just under 7% of adults in the United States continue to struggle with symptoms of long COVID.

Intravascular imaging during PCI: Should cardiologists choose IVUS or OCT?

Which modality should care teams choose for PCI guidance? While there's an argument to be made for choosing IVUS over OCT, some specialists think the two treatment options are close to equal in terms of patient outcomes.

Shockwave Medical, a Johnson & Johnson MedTech company, has officially launched its Shockwave E8 Peripheral IVL Catheter in the United States. Shockwave’s E8 catheter was designed specifically to treat patients with calcified femoropopliteal and below-the-knee (BTK) peripheral artery disease (PAD), including those diagnosed with complex chronic limb-threatening ischemia (CLTI).

Shockwave Medical launches new FDA-approved IVL catheter for PAD, CLTI

The new device, already cleared by the FDA, was designed to treat femoropopliteal and below-the-knee PAD.

Biotronik has received U.S. Food and Drug Administration (FDA) approval to make its Solia S lead and Selectra 3D catheter available for a new indication: left bundle branch area pacing (LBBAP).

FDA approves Biotronik lead, catheter for left bundle branch area pacing

LBBAP is a relatively new alternative to biventricular pacing. The FDA's decision was based largely on data from the BIO-CONDUCT clinical trial.

SpectraWAVE, a Massachusetts-based imaging company focused on treatments for patients with coronary artery disease (CAD), has closed a $50 million funding round. Johnson & Johnson Innovation led the round, and other participants included S3 Ventures, Lumira Ventures, SV Health Investors, Deerfield Management, NovaVenture and Heartwork Capital.

SpectraWAVE raises $50M for FDA-cleared intravascular imaging technology

The funds, including a significant investment from Johnson & Johnson, are expected to go toward expanding access to the company's HyperVue Imaging System and exploring new features.

Clinical

Shockwave Medical launches new IVL catheter for challenging lesions in Europe

FDA clears Apple Watch algorithm for detecting hypertension

Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

Cardiologist sues hospital after he was allegedly let go for sharing safety concerns