The Food and Drug Administration approved a breakthrough medical device last week for patients suffering from chronic, hard-to-treat heart failure.
div > div.group > p:first-child"> The Optimizer Smart System, created by Impulse Dynamics, monitors heart activity and delivers non-excitatory electrical signals to the right heart valve.
"These are patients who have a marked limitation of physical activity and who remain symptomatic despite receiving optimal medical therapy," according to an FDA release.Cardiac resynchronization therapy is a common treatment, aside from medications and lifestyle changes, but isn't suitable for about 70 percent of patients with moderate-to-severe heart failure, according to a release from Impulse Dynamics.
It's similar to a pacemaker but different in function. Unlike a pacemaker, which regulates the rhythm of the heart, the OSS strengthens the muscle contractions. As a result, the device can improve the patient's quality of life, their performance on a six-minute hall walk distance test and their functional status compared to those who only took medications.
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA says cybersecurity vulnerabilities found in some Medtronic devicesThe U.S. Food and Drug Administration (FDA) on Thursday said cybersecurity vulne...
Read more »
FDA approves the first drug designed to treat postpartum depressionThe FDA approved the first drug specifically for postpartum depression, a debilitating condition that affects about 400,000 women a year in the United States.
Read more »
FDA puts partial hold on clinical trials of AbbVie's cancer drugAbbVie Inc said on Tuesday the U.S. Food and Drug Administration placed a partia...
Read more »
FDA approves first postpartum depression drugThe US Food and Drug Administration announced on Tuesday it has approved the first medication specifically targeted to treat postpartum depression in women. The treatment is administered as a single 60-hour IV drip, and could offer new hope to moms.
Read more »
‘Transformative’: FDA approves first drug for postpartum depressionBrexanolone is not a pill. The drug is delivered intravenously over the course of a 60-hour infusion, meaning it must be administered in a medically supervised setting, such as a skilled facility or a hospital, rather than at patients’ homes.
Read more »
Sage Therapeutics’ Drug for Postpartum Depression Gets FDA NodU.S. health regulators on Tuesday approved Sage Therapeutics Inc.’s Zulresso, the first medication specifically intended for women with postpartum depression.
Read more »
FDA approves first treatment for postpartum depressionThe FDA has approved a new medication called Zulresso, a completely new class of drug designed specifically to treat postpartum depression. It’s a one-time infusion given in a hospital over two and a half days.
Read more »
FDA issues warning to two breast implant makers over safety concernsLess than a week before a major hearing on breast implant safety, the FDA issued two warning letters to implant manufacturers, citing their failure to do proper safety studies.
Read more »
FDA considers yanking nicotine vaping pods off the marketU.S. Food and Drug Administration Commissioner Scott Gottlieb said Tuesday that his agency may need to pull pod-based nicotine products off the market as it fights a surge in teen vaping.
Read more »