Doctors trying to diagnose the cause of chronic fainting will soon have a new medical device in their tool kits.
Little Canada-based St. Jude Medical said Thursday the U.S. Food and Drug Administration has given it clearance it to start selling its first implantable cardiac monitor, SJM Confirm. (Medtronic sells a similar device called Reveal.)
The devices are designed to help doctors diagnose symptoms including syncope, or unexplained fainting, a condition that affects about 1 million Americans, or about one in 300 people.
Dr. Alan Berger of the University of Minnesota’s Division of Cardiology said diagnosis is important because the fainting can be caused by abnormal heart rhythms, which may require treatment. According to Medtronic, cardiac problems are behind at least 10 percent of syncope cases, and another 40 percent are never diagnosed.
One common tool used to check for irregular heart rhythms is an external device called a Holter monitor, which is made by various companies. Patients carry the fist-sized machine in a pocket or around their neck for usually one to two days, during which it records heart rhythms.
When physicians don’t recognized anything out of the ordinary in the Holter monitor data but the patient’s symptoms continue unexplained, implantable cardiac monitors like the new St. Jude device offer a way to track heart activity over a longer period of time, usually six to 12 months. St. Jude said its device’s batteries last three years.
“The SJM Confirm ICM was developed in response to physicians’ need for more information about heart rhythm abnormalities, particularly in patients who are most challenging to diagnose,” said Dr. Eric Fain, president of St. Jude Medical, in a statement.
SJM Confirm is the world’s smallest implantable cardiac monitor, according to the company. It’s about the size of a computer thumb drive. The device is implanted just under the patient’s skin near the collar bone, using local anesthesia.
The device constantly records the patient’s heart rhythms and transmits the data to a remote-monitoring station, where it is uploaded to a secure site for a physician to review. It can be programmed to alert the doctor if certain patterns appear in the patient’s heart rhythms.
St. Jude said it will begin selling the SJM Confirm device in October.