Melody Transcatheter Pulmonary Valve – P140017
This device is an artificial heart valve. It is made from the jugular vein of a cow and sewn into a metal frame. It can be inserted into the heart while it is still beating and without performing open-heart surgery.
This device is use in patients who are born with heart defects. Normally, patients with heart defects must undergo many surgeries throughout their lifetime. Using the Melody TPV can delay the need for surgery and in some cases, it can result in the patient needing fewer surgeries overall.
KAMRA Inlay – P120023
This is a dark, ring-shaped device that is implanted into the cornea. It can be used to improve near vision for patients whose eyes have trouble focusing. The device works by blocking unfocused light.
This device is usually used for patients who are between 45 and 60 years old. It can help patients who have trouble focusing clearly on small print or nearby objects, but who do not have a problem with distance vision.
ORBERA™ Intragastric Balloon System – P140008
This is a weight loss device. It is a balloon that occupies space inside the stomach. It is placed inside the body using a minimally invasive procedure. It is inserted through the mouth. Once it is inside the stomach it is filled with salt water. This device is meant to be removed after 6 months.
It is used on obese patients who haven’t been able to lose weight through diet and exercise. It helped patients to lose an average of about 10.2% of their body weight.
These are just a few of the medical devices that have been approved throughout the year. These devices, and many others can improve the health and lifestyle of patients. If you’d like to learn more about new medical devices, or if you’d like to train your staff to use new medical devices, contact Med Ed Labs.