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 announces new recall of delivery catheters after patient’s death
The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.
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.
New lawsuit alleges a woman’s brain bleed was mistaken for drunken driving, causing significant harm
A Washington woman was pulled over and arrested because a state trooper thought she was driving under the influence. It turned out that she was not drunk, but suffering from a frontal-lobe subdural hematoma. She has now filed a lawsuit against the county.
FDA announces Class I recall of nearly 2,000 catheter kits
Medical facilities and distributors have been advised to immediately discontinue the use of these devices due to a significant labeling issue.
CMS changes coverage policy for carotid stenting to make it more widely available
A group of interventional cardiologists, neurologists and vascular surgeons successfully petitioned Medicare to change its coverage determination for carotid stenting procedures.

FDA announces new recall of delivery catheters after patient’s death

The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.

May 10, 2024

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.

April 17, 2024

New lawsuit alleges a woman’s brain bleed was mistaken for drunken driving, causing significant harm

A Washington woman was pulled over and arrested because a state trooper thought she was driving under the influence. It turned out that she was not drunk, but suffering from a frontal-lobe subdural hematoma. She has now filed a lawsuit against the county.

February 9, 2024

FDA announces Class I recall of nearly 2,000 catheter kits

Medical facilities and distributors have been advised to immediately discontinue the use of these devices due to a significant labeling issue.

November 7, 2023

An interactive diagram for the carotids and arteries of the brain for interventional reporting shown by Fujifilm at HIMSS 2023. Photo by Dave Fornell

CMS changes coverage policy for carotid stenting to make it more widely available

A group of interventional cardiologists, neurologists and vascular surgeons successfully petitioned Medicare to change its coverage determination for carotid stenting procedures.

October 18, 2023

Expanding Medicaid linked to better care for heart patients

New research, based on data from approximately 143 million patients, focused on prescriptions for heart failure, atrial fibrillation and other significant cardiac conditions.

August 3, 2023

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

Nearing a ‘breaking point’: Cardiologists support legislation designed to mitigate Medicare cuts to office-based services

These latest cuts could be a "breaking point" for physicians, according to a new letter to lawmakers.

June 2, 2023

Around the web

AI in Healthcare

About that bipartisan $32B ‘roadmap’ for AI policy: What’s in it for healthcare?

This week Washington took a major step toward nailing down a solid game plan on federal AI spending for everything outside of defense.

Cardiovascular Business

FDA announces new recall of delivery catheters after patient’s death

The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.

Cardiovascular Business

FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls

The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible.