Patients suffering from blockages of the arteries to the kidneys now have access to a new stenting treatment option with the launch today of Cook Medical's Formula™ Renal Balloon-Expandable Stent at the Society for Cardiovascular Angioplasty and Intervention (SCAI) 2011 Scientific Sessions. 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.
"The launch of Formula marks a milestone in our mission to provide physicians new options to treat renal artery disease, addressing lesions with interventional technologies that provide control and precision," said Rob Lyles, vice president and global leader of Cook's Peripheral Interventional business unit. "In 2011, there will be an estimated 53,400 renal stenting procedures done in the U.S., with roughly 1.06 stents used per procedure. With Formula and, more broadly, Cook's newly introduced Renal Therapies Program, we can now offer an array of tools to truly advance treatment for patients across the U.S."
Data from Cook's REFORM clinical trial, which assessed the safety and efficacy of the Formula stent, revealed a nine-month primary patency rate of 91.7 percent. Robert Bersin, M.D., REFORM's principal investigator and medical director of endovascular services at Seattle Cardiology and Swedish Medical Center, will discuss these results at SCAI 2011. Dr. Bersin will also facilitate a lunchtime symposium, "New Developments in the Treatment of Renal Artery Disease: Emphasis on Technique, Safety and Outcomes," taking place Thursday, May 5 at 12:00 pm EDT.