Dr. James Thompson was at a conference in January 2017 when he saw a talk on a new technology that piqued his interest.
He got in touch with the company behind the device, obtained government approval for a study to see how well it works, and, since fall, has performed more than 60 heart procedures with it.
“We’ve had people come from all over the country,” the Virginia cardiologist said, noting many have heard about it through a Facebook patient support group. “It’s amazing. It’s the most amazing piece of technology I’ve seen since graduating medical school.”
The device, called NobleStitch, is essentially a suture delivery system. It provides a new way for doctors to stitch up holes in a patient’s heart.
The technology has been available in Europe for about a decade but wasn’t approved by the U.S. Food and Drug Administration (FDA) until last year.
It’s currently being used at Inova Health System, the network of hospitals in Virginia where Thompson works.
After further studies in the U.S., Thompson hopes to see it being used across the country.
“My prediction is once we get that data, people will flock to it,” he told Healthline.
A common ailment
About one in four adults has a hole in their heart called a patent foramen ovale.
For some of those people, that hole can increase the risk of stroke by allowing blood clots to bypass the lungs, where they would be filtered out, and eventually reach the brain.
Inova says that half of those who have a stroke before 65 have a hole in their heart, and that stitching that hole closed reduces the chances of a second stroke by 75 percent.
A couple decades ago, that would have required open heart surgery.
Today, that typically requires going in through the patient’s groin and inserting a device on the other side of the hole to close it.
That’s a low risk and typically effective procedure. However, Thompson said, it’s not perfect.
Clots can form around the device that’s left behind, typically about 20 millimeters in size. An irregular heartbeat can occur, at least temporarily. Sometimes the device can work its way to elsewhere in the heart.
Some patients may also be sensitive to the nickel in the device, which have made migraines worse.
And it might get in the way of future heart procedures.
Thompson had his first case of “device erosion” last year, which resulted in an emergency room stay. He said the erosion happens in one to three patients in 1,000.
“It’s safe and effective, but we’re always trying to make it better,” he said.
The next step
He sees NobleStitch as the next step in this evolution.
To use it, he sends what’s essentially a catheter up the blood vessels from the groin to the heart.
There, an arm with thread comes out of the tube, a needle catches it similar to the way a sewing machine needle is threaded, a stitch is made on the other side of the hole. From there, thread is passed, the hole is cinched closed, a little blade cuts the suture, and a cylinder about 2 millimeters big locks it in place.
The stitching takes about five minutes, although with ultrasounds and setup, the whole procedure takes 30 to 40 minutes.
Thompson said it’s been successful in all of the 60 times he’s used it, in addition to the pig hearts he tried it on initially.
“The guy who designed it, how he made it you’d have to purposely try to mess up to have a problem,” he said. “And, if for some reason it didn’t work, you could just pull the suture out and use a traditional device.”
The guy who designed the procedure is Anthony Nobles, PhD, whose website states his 70 medical device patents are “more than virtually any other single individual in the world.”
“There is significant interest (in NobleStitch) from physicians in the U.S. and from patients… in Europe,” Nobles told Healthline. “No shortage of people who are interested, let’s put it that way.”
Looking for approval
Thompson said the product could already be used by any hospital in the United States, although they don’t yet have FDA approval to market it as a way to reduce the risk of strokes.
Nobles’ company, HeartStitch, is currently recruiting U.S. hospitals in hopes of putting together a study in the next couple months that could result in that approval.
The procedure has already been proven in other studies with other devices, he said. The research has shown that closing a hole in a heart reduces risk of recurrent stroke and that NobleStitch is safer than existing technologies, he added.
One such study finding that closing the hole reduces stroke risk was presented last week at the American College of Cardiology’s conference in Florida.
Patients who had experienced a stroke were either given anticoagulant drugs to reduce clotting or had the hole in their hearts closed with a traditional device. None of the ones who received the device experienced another stroke in the two years following the procedure. Ten percent of the ones who got only the medications did.
Dr. Jae Kwan Song, a cardiologist at Asan Medical Center in South Korea who conducted the new study, told Healthline he was not aware of NobleStitch and wondered whether a simple stitch would be appropriate for all patients, since the types of holes can vary.
But, he said, “it is interesting to see some European doctors in the E.U. reported that the clinical outcome study using NobleStitch showed higher success rate and lower complication compared to the recent clinical trials that used different devices.”