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.

Echo:Prio represents the latest addition to Dyad Medical's cloud-based Libby platform. Image courtesy of Dyad Medical.

Regulatory Roundup: FDA approves new-look self-expanding stent, clears 2 advanced AI models

The FDA has had a busy month, overseeing the recall of nearly 88,000 implantable cardiac devices, juggling the continued rise of monkeypox cases in the United States and maintaining an active Breakthrough Devices program. This rundown covers some of the agency's biggest moves during that time.

August 24, 2022

When kidney cancer invades a patient’s inferior vena cava (IVC), robotic-assisted radical nephrectomy with IVC thrombectomy is a safe and effective alternative to open surgery, according to a new meta-analysis published in the Journal of Urology.[1]

Robotic IVC thrombectomy: A safe, effective alternative to open surgery

A new meta-analysis of 28 different studies confirmed that robotic-assisted radical nephrectomy with IVC thrombectomy is a safe treatment option for kidney cancer.

August 22, 2022

A heart attack is caused when one of the coronary arteries becomes blocked with a clot.

Study the signs: The most common symptoms of 6 cardiovascular diseases

A new scientific statement details the most common symptoms associated with heart attacks, heart failure and other cardiac conditions. Importantly, the authors wrote, clinicians must remember that symptoms can vary between men and women.

August 19, 2022

Interventional cardiologists at the University of Washington (UW) have used the new Ōnocor catheter-delivered retrieval device to remove a benign tumor from a patient’s heart. This is the first time such a device has ever been used to remove a heart tumor.

Cardiologists make history, becoming first to use FDA-cleared retrieval device to remove a heart tumor

The historic procedure took approximately 30 minutes, and the patient went home that same day.

August 18, 2022

Boston Scientific acquires startup behind new FDA-cleared embolization technology

The new hydrogel material was designed to immediately conform to the patient's body and create a barrier.

August 15, 2022

The Harmony pulmonary valve was among the devices involved with the FDA Breakthrough Device Designation program that gained more rapid market clearance. The FDA graph shows cardiovascular devices leading the types of devices involved in the program.

Cardiovascular devices lead FDA Breakthrough Device Designation program

The FDA said cardiovascular devices make up the largest number of technologies accepted into the Breakthrough Devices Program, and several are on the list of the first 50 in the program to gain market clearance.

August 4, 2022

Cardiologists sound the alarm as ‘staggering’ new data suggest CVD rates in the U.S. will rise dramatically

New data from the CDC and U.S. Census Bureau show just how bad CVD rates could get in the next few decades. Specialists agree that a lot of work is needed to help keep these estimates from becoming a reality.

August 2, 2022

Researchers said they were surprised to learn that "no pain, no gain" was so accurate for patients with peripheral artery disease (PAD). A news study found patients should push past the pain because it improves outcomes.

Peripheral artery disease patients benefit if they push through discomfort when walking

Researchers said they were surprised to learn that "no pain, no gain" was so accurate for this patient population.

July 29, 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