Vascular & Endovascular

This channel includes news on non-coronary vascular disease and therapies. These include peripheral artery disease (PAD), abdominal and thoracic aortic aneurysm (AAA and TAA), aortic dissection, pulmonary embolism (PE), critical limb ischemia (CLI), carotid artery and stroke interventions, venous interventions, deep vein thrombosis (DVT), and interventional radiology therapies. The focus on most of these therapies is minimally invasive, catheter-based procedures performed in a cath lab.

FDA clears new catheter for peripheral blood clots
The new-look catheter came out of a medical device incubator started by entrepreneur Eitan Konstantino, PhD, who has years of experience in the vascular space.
Boston Scientific recalls premixed embolic agent after two deaths
There have been a total of 11 incidents so far, including seven injuries and two deaths. Boston Scientific said the agent can still be used if operators follow specific instructions during lower GI bleed embolization procedures.
Anemia may help explain why women are more likely to die during heart bypass surgery
Finding new ways to avoid intraoperative anemia could go a long way toward improving outcomes for female CABG patients. The full analysis, based on more than 1.4 million patients, was published in the Journal of the American College of Cardiology.
FDA grants anticoagulant its orphan drug designation for treating patients with implanted devices
The anticoagulant was originally developed for patients with end-stage renal disease and atrial fibrillation.
FDA announces new recall of neurovascular catheters built by Johnson & Johnson subsidiary
The recall is due to ongoing concerns about the devices breaking. Three patients have been injured as a result of this issue.

Medtronic has received FDA approval for its IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter. FDA clears new drug eluting balloon, drug-coated balloon.

FDA says treating PAD with paclitaxel-coated devices does not increase mortality risk

After warning healthcare providers about a heightened risk of mortality back in 2019, the FDA has now updated its stance on the use of these devices.

July 11, 2023

IVUS guidance during DES implantation boosts long-term outcomes in new study

Heart failure symptoms after PCI increase risk of adverse events

Researchers in Japan tracked BNP levels and bleeding events among more than 7,000 PCI patients. The group noted that managing heart failure in the first 30 days after PCI can help boost outcomes.

July 7, 2023

Balloon expansion deployment of an Edwards Lifesciences Sapien 3 transcatheter aortic valve replacement (TAVR) device.

TAVR vs. surgery: Exploring 5-year outcomes among intermediate-risk patients

A group of renowned TAVR specialists examined data from 783 pairs of intermediate-risk patients, sharing their findings in the Journal of the American College of Cardiology.

July 6, 2023

FDA announces recall of more than 250,000 interventional devices due to risk of catheter separation

The FDA has said this is a Class I recall, which means using the devices “may cause serious injuries or death.” A total of 18 injuries have been reported so far.

June 27, 2023

Private equity-backed cardiology group continues busy year with acquisition of Florida practice

Cardiovascular Associates of America, which has already had an eventful 2023, announced a new acquisition that helps expand its footprint in the Sunshine State.

June 22, 2023

The Surmodics SurVeil drug-coated balloon to treat peripheral artery disease.

FDA approves next-gen DCB, earning the manufacturer a $27M payment from Abbott

The new-look DCB was designed to provide care with a significantly lower drug load than similar devices.

June 20, 2023

Cardiologist agrees to pay $5M for overstating heart findings to justify unnecessary procedures

The North Carolina physician allegedly performed unnecessary atherectomy procedures to treat minor blockages in the leg arteries of multiple patients.

June 15, 2023

The Pounce Thrombectomy System by Surmodics. The company just gained FDA clearance on a new version of the system for smaller arteries.

FDA clears new ‘grab-and-go’ interventional device for below-the-knee blood clot removal

The new device was designed to remove thrombi and emboli from peripheral arteries ranging from 2 to 4 mm.

June 14, 2023

Vascular & Endovascular

FDA clears new catheter for peripheral blood clots

Boston Scientific recalls premixed embolic agent after two deaths

Anemia may help explain why women are more likely to die during heart bypass surgery

FDA grants anticoagulant its orphan drug designation for treating patients with implanted devices

FDA announces new recall of neurovascular catheters built by Johnson & Johnson subsidiary