MORGANTOWN – A team of officials from Recor Medical and Tokyo-based Otsuka Medical Devices came to Mon Health Medical Center Thursday morning to see how the cardiology team there is making successful use of their innovative device to treat high blood pressure.
Recor Medical, a subsidiary of Otsuka, developed the Paradise Ultrasound Renal Denervation (uRDN) system and Mon Health is among the first 10 hospitals in the nation to offer the procedure using the device. Mon Health and its Vandalia sister CAMC are the only two hospitals in the state to offer it.
Mon Health’s team, the officials and a couple of the first patients to benefit from it sat around a table to talk about the Paradise uRDN.
Dr. Wissam Gharib performed a procedure in February on Richard Austin, 72, who told the group he’s suffered from high BP – also called hypertension – since his early 20s.
“It’s just been a blessing and a good fortune to be with Dr. Gharib here and have this opportunity,” Austin said.
Blood pressure readings have two numbers and look like, for example, 120/60. The first, upper, number is called the systolic pressure, and Austin said his fell from the 150-160 range to 110 after the procedure – excepting a recent stress-related elevation.
The only after-effect, he said, was little bit of back pain for a couple weeks, but that’s long passed.
Gharib performs most of these procedures at Mon Health and explained how it works.
The procedure is called renal denervation because the adrenal glands that sit atop the kidneys produce a neurotransmitter/hormone called norepinephrine, high levels of which can cause hypertension. The goal of the procedure is to reduce the norepinephrine levels and break the communication between the kidneys and the brain to reduce the blood pressure.
They start by inserting a tube through the groin up into the abdominal aorta to locate the renal artery. Then a catheter is sent into the artery to measure its size. From there, they insert a balloon – from 3-8 millimeters depending on the artery size – that touches the artery wall all the way around.
The balloon delivers ice-cold water to protect the artery. “So, you basically have a doughnut of protection.”
Then the Paradise uRDN emits ultrasound energy to burn the nerves. The process involves three burns in three locations along the artery, each burn lasting about 7 seconds.
The procedure reduces norepinephrine release by 90%, he said.
This is early-stage deployment of the device, he said. They are selecting the most complex cases – patients on six to seven hypertension medications who aren’t seeing their BP controlled. Down the line, as they learn more, they may be able to perhaps offer it to patients on just one or two medications.
Physician Assistant Jordan King presented some statistics: They performed the first case in December 2023 and have done 20 so far. The average patient age is 69.8 and 72% are male.
The average procedure time – performed under twilight sedation as most caths are – is 37.3 minutes. The average reduction in systolic pressure after 90 days is 19.86 and the largest reduction was 66 after 30 days.
The Paradise uRDN is one of two FDA-approved renal denervation systems. Gharib said they looked at both. The other one uses radio frequency ablation to burn the nerves and the body’s blood to cool the artery. With this one, the burn is shorter and more tolerable by patients.
Patient Jack Daft is 67. He’s a Type 1 diabetic, he said, and his systolic pressure was up in the 190s-210s – stroke risk level. He underwent the procedure a few months ago and it dropped into the 130s and 140s. It’s still fluctuating a bit as they adjust his medications.
“Right now, things are looking better,” he said. “The procedure itself was easy to go through.”
California-based Recor Medical explained that the Paradise was developed in the U.S. about 14 years ago and took time to get to market. Otsuka acquired Recor in 2018 and supported Recor in the development. The Paradise received FDA approval last November and has scaled up since.
The officials who came to Mon Health were Lara Barghout, CEO of Recor Medical; Noriko Tojo, Record board chair and president of Otsuka Medical Devices; and Kazumichi Kobayashi, Recor board member and Otsuka Medical Devices deputy executive president.
Before coming to Morgantown, they also visited Henry Ford Hospital in Detroit and Cleveland Clinic.
Barghout said, “The team here at Mon Health, they’re ahead of the game. The way they’ve structured the program here is best in class, I would say. Something to teach in other parts of the country.”
She said, “This is why we do what we do. Everything we do on a daily basis is to reach as many patients as possible and impact the lives of patients and give you a normal life under hypertension.”
And Tojo told the group, “It’s been a long journey to get to this stage. … This is so rewarding, making a difference in people’s lives. That’s what we are here for.”
Email: dbeard@dominionpost.com
