The University of Toledo Medical Center is one of the first hospitals to treat cardiac patients with a newly-approved, revolutionary device.

“I know that for these people who live very close to us, we can have the confidence that they could not have gotten better care anywhere else in the world,” said Dr. Mark Burket, chief of the Division of Cardiovascular Medicine, director of vascular medicine, director of cardiovascular research and professor of medicine.

The Lutonix drug-coated angioplasty balloon is the first of its kind to be approved by the Food and Drug Administration (FDA). It received final approval in early October, and is the only drug-coated balloon currently marketed in the United States.

UTMC participated as a clinical site for the LEVANT-2 study, which led to the FDA approval of the balloon. The balloon is primarily for use in patients with peripheral arterial disease (PAD), a circulatory disease in which narrowed arteries reduce blood flow to the limbs.

“We were quite privileged to be able to participate in this trial. By participating, we were among the first to receive the balloons once they received FDA approval. The first person in northern Ohio to receive the treatment was a UT employee, treated at UTMC,” Burket said.

Four patients have been treated with the device at UTMC.

The study compared the safety and effectiveness of the drug-coated balloon with a standard balloon.

“The approval of this device is extremely important to patients who suffer from blocked arteries to the legs. Opening obstructions with a balloon is much safer than performing surgical bypass, but the limitation of balloon angioplasty is that blockages can recur,” Burket said.

The Lutonix balloon releases a drug, paclitaxel, which limits the growth of scar tissue after a blocked artery has been opened.

“The outer surface of the balloon is coated with paclitaxel. When the balloon inflates, the drug is transferred to the wall of the vessel. The drug suppresses scar formation, thus ensuring that the vessel won’t clog up again,” said Burket. “Paclitaxel significantly decreases recurrence, so patients are more likely to have permanent relief of leg pain.”

“UTMC’s Cardiovascular Division was invited by Lutonix to participate in this study because we had extensive experience in clinical research in peripheral vascular disease. For example, UT was the top U.S. university center for enrollment in Zilver PTX, a clinical trial in which a drug-coated stent was used to treat blockages in the same artery that was treated in the Lutonix study,” Burket said.

Participation in the LEVANT-2 required dedication from the entirety of the cardiovascular staff.

“We are dependent upon our research coordinators to carefully attend to every detail for enrollment, data-entry and follow-up. The first-rate staff in the Cardiovascular Lab ensures that we have the right equipment, that imaging is complete and of the highest quality,” Burket said.

A second drug-coated balloon received FDA approval in early January.

“We are proud to have been involved with the trial and approval of the Lutonix balloon. The distribution and use of this device, and others like it, will greatly benefit patients affected by PAD, and will ensure they receive quality treatement,” Burket said.

Tags: The University of Toledo Medical Center (UTMC)