Peripheral Artery Disease, also known as PAD, affects about eight million Americans. It is a narrowing of arteries in the arm or leg. The risk increases with age, and for people with high blood pressure, high cholesterol, or diabetes. The threat is even greater for smokers. People with PAD are four to five times more likely to suffer a heart attack or stroke. It can also lead to gangrene and amputation.
Researchers at the Jobst Vascular Institute in Toledo, Ohio, are participating in one of the largest peripheral vascular studies ever and the first drug-coated balloon. Levant 2 is a global clinical trial studying the effectiveness of a new device called the Moxy Drug Coated Balloon compared to standard balloon angioplasty for the treatment of PAD. The Moxy balloon is coated with a drug called Paclitaxel which is currently used to treat a variety of diseases, such as certain types of cancer. It is also used as a coating on stents, which prop open blocked heart arteries. The device is inflated for 30 seconds in the narrowed vein and restores blood flow while coating the artery with the drug which may work to prevent re-blockage. Patients will be randomized to receive either treatment with the Moxy Drug Coated Balloon, or with a standard angioplasty balloon.
Jobst Vascular Surgeon John Pigott, MD, is performing a case study at ProMedica Toledo Hospital and says that he is encouraged by the preliminary results from first-in-man trials.
“This new device could significantly change the way PAD is treated in the future and may benefit a broad range of patients,” says Dr. Pigott.
Jobst Vascular Institute is a member of ProMedica, a mission-based organization that is ranked the No. 2 most integrated health system in the U.S. ProMedica was formed in 1986 and is a Toledo, Ohio-based, not-for-profit healthcare organization with nearly 14,000 employees; 3,000 physicians and more than 306 facilities in Ohio and Michigan. ProMedica serves more than 2.73 million patients annually and includes 11 hospitals; ProMedica Continuum Services with senior, hospice, rehabilitation, and integrative services; ProMedica Physicians, a network of more than 315 primary care and specialty physicians; and Paramount Health Care, the largest HMO in northwest Ohio.
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