NATICK, Mass.—The U.S. Food and Drug Administration has approved Boston Scientific’s new renal stent, which is designed to help hold open arteries that provide blood to the kidneys.
Boston Scientific’s Express SD Stent is approved for use as an adjunct to PTRA (percutaneous transluminal renal angioplasty) in certain lesions of the renal arteries. The company said it is the only FDA-approved renal stent designed to provide additional proximal end support.
"FDA approval for the Express SD Renal Stent is an important step in providing physicians evidence-based technology to facilitate the management of renal artery disease," said Jim Tobin, president and CEO of Boston Scientific. "With the addition of the Express SD Renal Stent, Boston Scientific can now offer customers the industry's leading portfolio of products for endovascular treatment of this disease."
Renal artery disease is the narrowing of the main blood supply to the kidneys due to atherosclerosis, or the formation of plaque within the arteries, which can lead to high blood pressure or poor kidney function.
The disease can be treated surgically, with medication, or less invasively with angioplasty. Re-narrowing of the arteries can occur after angioplasty, and the use of stenting as an adjunctive treatment option is intended to assist in their re-opening.
Two-year results from a clinical trial, which was designed to evaluate the safety and efficacy of the Express SD Renal Stent in hypertensive patients with atherosclerotic renal artery stenosis (RAS), demonstrated a statistically significant improvement in systolic blood pressure and no statistical difference in either diastolic blood pressure or serum creatinine levels from baseline through three years.