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.

The CardioMEMSHF system measures pulmonary artery pressure and and sends this information remotely to the patient's doctors, the FDA said Wednesday in a news release.

The device is intended for people with New York Heart Association Class III , the FDA said. Some 5.8 million people in the United States have heart failure, in which the heart can't pump enough blood. People with NYHA Class III heart failure have difficulty performing everyday tasks such as walking short distances, the agency said.

The device was evaluated in a clinical study involving 550 people. All devices implanted were still working after six months, the FDA said.

The agency said it is requiring a post-approval study to gather information about the device's long-term performance.

The system is manufactured by CardioMEMS Inc., based in Atlanta.

Explore further: FDA OKs HeartWare device for transplant patients

More information: Visit the FDA to learn more about this approval.

Related Stories

FDA OKs HeartWare device for transplant patients

November 20, 2012
The Food and Drug Administration on Tuesday approved a new heart pump for patients with severe heart failure who are awaiting a heart transplant.

FDA approves expanded indication for CRT devices

April 15, 2014
(HealthDay)—The U.S. Food and Drug Administration has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D). ...

IN-TIME shows equal benefit of home telemonitoring in ICD and CRT-D patients

May 19, 2014
Home telemonitoring is equally effective in ICD and CRT-D patients, a subanalysis of the IN-TIME trial has shown. The findings were presented for the first time today at the Heart Failure Congress 2014, held 17-20 May in ...

Blood pressure drugs help keep heart trouble at bay, FDA says

May 6, 2014
(HealthDay)—High blood pressure affects about one-third of American adults and raises their risk for heart attack, stroke, heart failure, kidney failure and death, but there are many medications available to lower blood ...

Daily aspirin regimen not safe for everyone, FDA warns

May 6, 2014
(HealthDay)—Taking an aspirin a day can help prevent heart attack and stroke in people who have suffered such health crises in the past, but not in people who have never had heart problems, according to the U.S. Food and ...

Recommended for you

Five vascular diseases linked to one common genetic variant

July 27, 2017
Genome-wide association studies have implicated a common genetic variant in chromosome 6p24 in coronary artery disease, as well as four other vascular diseases: migraine headache, cervical artery dissection, fibromuscular ...

Could aggressive blood pressure treatments lead to kidney damage?

July 18, 2017
Aggressive combination treatments for high blood pressure that are intended to protect the kidneys may actually be damaging the organs, new research from the University of Virginia School of Medicine suggests.

Quantifying effectiveness of treatment for irregular heartbeat

July 17, 2017
In a small proof-of-concept study, researchers at Johns Hopkins report a complex mathematical method to measure electrical communications within the heart can successfully predict the effectiveness of catheter ablation, the ...

Concerns over side effects of statins stopping stroke survivors taking medication

July 17, 2017
Negative media coverage of the side effects associated with taking statins, and patients' own experiences of taking the drugs, are among the reasons cited by stroke survivors and their carers for stopping taking potentially ...

Study discovers anticoagulant drugs are being prescribed against safety advice

July 17, 2017
A study by researchers at the University of Birmingham has shown that GPs are prescribing anticoagulants to patients with an irregular heartbeat against official safety advice.

Protein may protect against heart attack

July 14, 2017
DDK3 could be used as a new therapy to stop the build-up of fatty material inside the arteries

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.