New device approved for tears in heart's blood vessels

September 15, 2018

(HealthDay)—The PK Papyrus Covered Coronary Stent System has been approved by the U.S. Food and Drug Administration to treat acute coronary artery perforations, the medical term for tears in the heart's blood vessels.

"An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel [surgery]," Dr. Bram Zuckerman, director of the FDA's Division of Cardiovascular Devices, said Friday in an agency news release. "The [device] provides with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure."

Such tears are a potential complication of surgery to clear clogged . The PK Pyrus device is a balloon-expandable covered coronary stent and delivery system, the FDA said.

The device was evaluated in a study of 80 people who had it implanted. In one instance, the device did not successfully seal the blood vessel tear and the patient later died in the hospital, the FDA said.

The device should not be implanted in people who aren't candidates for the clog-clearing procedure known as a PCI (), nor should it be implanted in people who are allergic to any material used in the system, the agency said.

The is produced by the German firm Biotronik.

Explore further: I have had a heart attack. Do I need open heart surgery or a stent?

More information: Visit the FDA to learn more.

Related Stories

I have had a heart attack. Do I need open heart surgery or a stent?

August 25, 2018
New advice on the choice between open heart surgery and inserting a stent via a catheter after a heart attack is launched today. The European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery ...

Percutaneous coronary intervention is a well-justified option in severe coronary artery disease

December 12, 2017
The treatment of left main coronary artery disease by percutaneous coronary intervention is associated with a smaller risk of severe cardiovascular events than coronary artery bypass grafting in the weeks following surgery. ...

'Smart stent' detects narrowing of arteries

June 19, 2018
For every three individuals who have had a stent implanted to keep clogged arteries open and prevent a heart attack, at least one will experience restenosis—the renewed narrowing of the artery due to plaque buildup or scarring—which ...

Anti-clotting drug approved for angioplasty

June 23, 2015
(HealthDay)—Kengreal (cangrelor) has been approved by the U.S. Food and Drug Administration to prevent blood clots from forming during angioplasty.

New blood pump system approved

March 24, 2015
(HealthDay)—The Impella 2.5 System has been approved by the U.S. Food and Drug Administration to maintain stable heart function and blood circulation during high-risk cardiac operations, the agency said in a news release.

Remote monitoring device approved for heart patients

May 29, 2014
(HealthDay)—An implanted wireless device that measures key vital signs in people with heart failure has been approved by the U.S. Food and Drug Administration.

Recommended for you

New treatment significantly reduces cardiovascular events when combined with statins

November 12, 2018
Statins are the most commonly used treatment for cardiovascular disease. Despite reducing certain risk factors, if triglyceride levels remain high with use of statins, there is still a significant risk for heart attack, stroke ...

Kawasaki disease: One disease, multiple triggers

November 12, 2018
Researchers at University of California San Diego School of Medicine, Scripps Institution of Oceanography, and international collaborators have evidence that Kawasaki Disease (KD) does not have a single cause. By studying ...

Study: How vitamin D and fish oil affect risk of heart attack, stroke and cancer

November 12, 2018
For years, it's remained an open question: What effects do dietary supplements such as high doses of vitamin D or omega-3 fatty acids derived from fish oil have on the risk of diseases such as heart attack, stroke and cancer? ...

Diabetes drug might also ease heart failure risks

November 12, 2018
(HealthDay)—The diabetes drug Farxiga might do double-duty for patients, helping to ward off another killer, heart failure, new research shows.

Updated cholesterol guidelines offer more personalized risk assessment, additional treatment options

November 12, 2018
More personalized risk assessments and new cholesterol-lowering drug options for people at the highest risk for cardiovascular disease (CVD) are among the key recommendations in the 2018 cholesterol guidelines from the American ...

Heart failure therapy improves outcomes for patients with acute illness

November 11, 2018
A drug therapy used for patients with chronic heart failure also improves markers of poor prognosis in individuals who are hospitalized with acute heart failure, new Yale-led research shows. The findings suggest that the ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.