A Medical Device Daily
Cook (Bloomington, Indiana) reported FDA approval to initiate the REFORM clinical trial, to evaluate the Formula Balloon Expandable Stent for the treatment of renal artery stenosis, a narrowing of the renal artery that can result in hypertension, renal atrophy and kidney failure.
The trial will evaluate safety/effectiveness of the Formula stent for the treatment of renal artery atherosclerosis against established performance data, enrolling up to 100 patients at up to 30 sites throughout the U.S.
Initial results are expected to be available in Q210, Cook said.
The trial’s first patient is undergoing treatment from the national principal investigator, Rajesh Dave, MD, chairman of Endovascular Medicine at Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital (Harrisburg, Pennsylvania).
Dave said, “The stent system ... doesn’t shorten and reliably opens up on both ends, which enhances my ability to place the stent more accurately. Our first patient had severely stenosed arteries within both kidneys, along with severe uncontrolled hypertension, but is now doing very well.”
The Formula Balloon Expandable Stent is intended for the long-term treatment of patients with atherosclerotic de novo or restenotic lesions following suboptimal angioplasty.
The device features a profile lower than many cobalt chromium stent platforms and does not shorten upon expansion, thus potentially improving placement accuracy across the diseased lesion. It also features an increased number of stent crowns to improve apposition to the renal artery wall.