Cook Medical has announced today the launch of its new Formula Renal Balloon-Expandable Stent for patients with renal artery stenosis. A company representative tells Medgadget that Formula will be the anchor product of Cook’s new Renal Therapies Program, which we also be announced today. The program encompasses “product training and support, clinical trials and a full line of minimally invasive products engineered specifically for the periphery.”
More about the product and indications for use:
Commercial availability of the Formula follows pre-market approval by the U.S. Food and Drug Administration (FDA) earlier this year for use in patients with atherosclerotic disease of the renal arteries.
Formula is approved for treatment of renal artery stenosis following suboptimal percutaneous transluminal renal angioplasty (PTRA) of de novo or restenotic lesions. Available in both over-the-wire or rapid exchange delivery systems (the Formula 418 and Formula 414RX, respectively), the stent will be the lynchpin product of Cook’s new Renal Therapies Program, which encompasses product training and support, clinical trials and a full line of minimally invasive products engineered specifically for the periphery.
Press release: Cook Medical Launches Balloon-Expandable Renal Stent at SCAI 2011 Scientific Sessions …