Cardiologists at Mississippi health system implant the nation’s first absorbable stent
Dr. Barry Bertolet (center), along with staff from the NMMC Cardiac Catheterization Laboratory and Cardiology of North Mississippi's research team, celebrate after implanting the nation's first absorbable stent.
TUPELO MISS. – Cardiologists at North Mississippi Medical Center's (NMMC) Heart Institute recently implanted the nation's first absorbable stent in a patient with severe obstructive coronary artery disease as part of an international research study.
Led by Tupelo interventional cardiologist Barry Bertolet, MD, the cardiology team at the NMMC Heart Institute implanted the first ABSORB™ stent in the United States on Dec. 28, just days after the FDA granted medical device maker Abbott (NYSE: ABT) approval for ABSORB’s domestic trial.
The ABSORB bioresorbable vascular scaffold (BVS) represents the world's first drug eluting bioresorbable vascular scaffold, a first-of-it is-kind device for treating coronary artery disease that works by restoring blood flow to the heart similar to a metal stent, but then dissolves into the body. The result: a treated vessel free of a permanent metal implant that may resume more natural function and movement.
“The procedure for implanting this device is similar to the procedure for implanting a metallic stent, which we do on a routine basis,” said Bertolet. “We’re excited about ABSORB because it may allow blood vessels to return to a more natural state and expand long-term diagnostic and treatment options for cardiac patients."
ABSORB is comprised of polylactide, a naturally dissolvable material that’s commonly used in medical implants such as dissolvable sutures. The device is referred to as a scaffold because it’s a temporary structure, unlike a stent, which is a permanent implant. The scaffold supports the vessel until the artery can stay open on its own, and then dissolves naturally.
“With this particular stent, we don’t need something that lasts forever,” said Bertolet. “We only need something that lasts six to nine months. By then, the blood vessel has had an opportunity to heal itself. Because the device disappears, it may reduce the need for long-term treatment with anti-clotting medication. It may also open up future options to avoid putting metal in patients’ arteries. ABSORB holds a lot of promise.”
The potential long-term benefits of a scaffold that dissolves also include broadening treatment and diagnostic options. Future interventions would be unobstructed by a permanent implant.
NMMC, the nation’s largest rural hospital, was selected as one of very few potential sites nationwide for the first ABSORB implant because the health system has a significant cardiology research program, said Bertolet.
“We’ve been selected many times over the years as a top national lead-off site in multiple clinical cardiology studies,” he said. “It just happened that in this trial, we found the first patient first. Our administrators did a lot of hard work in the background to make sure we were one of the first sites selected. That’s a testimony to their hard work.”
Bertolet noted that of the five ABSORB clinical trials outside the United States, Abbott has changed the protocol “a couple of times, but in essence, there are two parts of it.”
“First is the phase we’re in that gave us the opportunity to implant the first one,” he explained. “Then there’s a randomized clinical trial. In that one big study, there will be two subgroups of 200 patients each – one for diabetic patients, and another subgroup that involves invasive testing of the arteries.”
Eventually, Abbott will have 220 sites involved in ABSORB testing across the United States.
The ABSORB BVS scaffold received CE Mark approval in the European Union (EU) for the treatment of coronary artery disease. Six months ago, ABSORB made its mark on Japan when its first patient was treated with the BVS device. Shigeru Saito, MD, director of Cardiology and Catheterization Laboratories, and vice president of Shonan Kamakura Hospital, led the team.
“Abbott's BVS technology has the potential to open up a new therapy option for physicians treating patients with coronary artery disease in Japan,” said Saito. “For Japanese patients, this technology (holds) tremendous appeal.”
Robert Hance, senior vice president of vascular trials for Abbott, said the global company is focused on developing revolutionary bioresorbable drug and device combination products that have the potential to change the way physicians practice medicine, and improve outcomes for their patients.
“The enrollment of the first Japanese patient in the global ABSORB trial (was) a significant milestone and an important contribution to evaluating this technology in patients with heart disease in Japan,” he said.
The device has a limited release size, yet this month, the company will provide participating teams with a diverse variety of sizes and lengths to treat a broader variety of patients, said Bertolet.
“Right now, the artery that requires the stent has to be the right size to accommodate the blockage,” he said.
Bertolet, 52, said the milestone is a very significant step forward in medicine.
“I’ve been practicing long enough to see things come and go,” he said. “I was doing cardiology procedures when we only had balloon angioplasty. While there’ve been some significant advances in cardiology, this is the next big thing.”