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.

RAAS inhibitors lower risk of aneurysm rupture among patients with high blood pressure

Researchers also noted that uncontrolled hypertension, exposure to second-hand smoke and untreated type 2 diabetes were all associated with a greater rupture risk.

June 3, 2022

The Advanta V12 and iCast (bottom image) balloon expandable covered stents were recalled by Atrium/Getinge because the balloons may not deflate quickly when using thicker contrast for endovascular use.

More than 68,000 stents recalled after multiple injuries

Dozens of customers have reported issues with the device’s balloon or catheter hub separating from the delivery system, mostly during off-label use in a patient's blood vessels.

June 2, 2022

Abbott’s FreeStyle Libre 3 glucose monitor gains FDA clearance

Regulatory Roundup: FDA clears 2 new devices, grants breakthrough designation to advanced AI model

Catch up on several recent FDA announcements, including an update on the agency's response to the COVID-19 pandemic.

June 1, 2022

Survival on the rise among high-risk pulmonary embolism patients

The study's authors examined data from more than 1.4 million patients, noting that pulmonary embolism response teams appear to be playing a significant role.

May 31, 2022

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.

Medtronic gains FDA approval for new DCB compatible with 0.018” guidewires

The drug-coated balloon was approved to treat patients with peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries

May 27, 2022

Dragonfly OpStar Imaging Catheter FDA recall May 2022

FDA announces Class I recall of 4,800 imaging catheters due to risk of vascular injury

There have been five reported incidents so far, including one patient injury.

May 26, 2022

Open AAA repair linked to better long-term outcomes than EVAR

However, the authors noted, 30-day survival is significantly higher after EVAR than open AAA repair.

May 26, 2022

Terry Bowers, MD, director of vascular medicine at Beaumont Hospital, Royal Oak, Michigan, and national co-chair of the Pulmonary Embolism Research Collaborative (PERC), explains the skillset needed for pulmonary embolism (PE) thrombectomy procedures. #PERT #PE

VIDEO: What interventional cardiologists need to perform pulmonary embolism thrombectomy

There is a national trend where cardiology is increasingly being called in to help with PE response teams (PERT) at hospitals. Terry Bowers from Beaumont explains what skills interventional cardiologists need for PE procedures.

May 25, 2022

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