Cook Medical has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Formula™ Balloon-Expandable Renal Stent System. The approval includes both the Formula 414RX Balloon Expandable Renal Stent and the Formula 418 Balloon Expandable Renal Stent.
“This approval greatly accelerates Cook Medical's evolution as a leading provider of stents for the peripheral vessels”
As stated in its approval letter, the FDA has said these devices are indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous transluminal renal angioplasty (PTRA) of de novo or restenotic lesions.
"This approval greatly accelerates Cook Medical's evolution as a leading provider of stents for the peripheral vessels," explained Rob Lyles, vice president and global leader of Cook's Peripheral Interventional business unit. "As we move forward with important new products aimed at improving the physician's ability to treat lesions with a new generation of stents and a dedicated suite of wires and balloons designed specifically for peripheral use, we hope to expand interventional treatment to patients who previously would not have had that treatment option."
The Formula 414RX Renal is a rapid exchange stent system with a 0.014" wire guide and the Formula 418 Renal is an over-the-wire system balloon with a 0.018" wire guide system. Both are engineered to cross lesions with high pushability, trackability and kink-resistance. Cook's Formula stents are low profile designs engineered to avoid shortening after deployment, allowing for precise placement.
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