Some news updates on heart issues for you this on this cold and snowy weekend.
FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients Device Provides Support for Those Who Are Not Acceptable Transplant Candidates
There have been several FDA approvals of medical devices. One such device, HeartMate II, was approved earlier this month. HeartMate II is a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation. It is indicated for patients for patients waiting for more complex procedures, including transplants. Here is how the device works:
Heart assist devices are surgically implanted mechanical pumps that help the heart’s ventricle pump blood to the rest of the body. HeartMate II consists of a small, lightweight blood pump implanted in a patient’s chest just below the heart. An electrical cable that powers the blood pump passes through the patient’s skin to an external controller worn around the patient’s waist.
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
The US FDA has issued a communication regarding the safety of the weight loss drug Meridia (sibutramine hydrochloride). Recent evidence showed that the drug can increase the risk for cardiovascular events such as heart attack and stroke. The FDA is advising health professionals not the use Meridia in patients with a history of cardiovascular disease.
FDA Approves First Percutaneous Heart Valve
The US FDA also approved this month the Melody Transcatheter Pulmonary Valve and Ensemble Delivery System by Medtronic. The device is the first percutaneous heart valve which can be implanted through a catheter, or tube, in a leg vein and guided up to the heart. The big advantage of this device is that it is less invasive than an open-heart surgery and can in fact delay the need for a more invasive intervention. It is intended to replace conduits, surgical implants used to treat patients with ccongenital heart defects of the pulmonary valve.
According to Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health:
“The FDA’s approval of Melody allows patients to undergo a much less invasive procedure to treat their heart conditionCongenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients.”
Cleveland Clinic Health Chats
Several heart(y) topics are on at the Cleveland Clinic Health Chats this coming February:
- February 1: Ask the Heart Doctor with Benico Barzilai, MD
- February 8: Keeping Your New Year’s Weight Loss Resolution with Maxine Smith, R.D., L.D.
- February 10: Hypertrophic Cardiomyopathy with Harry Lever, MD
- February 22: Atrial Fibrillation – The Most Common Irregular Heart Rhythm with Bruce Lindsay, MD
- February 17: Alternative Treatment Options for Managing Your Health with Tanya Edwards, MD, MEd
Have a nice weekend!
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