FDA Approves Cook Medical's Formula Renal Stents, REFORM Data Presented at ISET

January 18, 2011—Cook Medical (Bloomington, IN) announced that it has received premarket approval from the US Food and Drug Administration for the 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. The devices are indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous transluminal renal angioplasty of de novo or restenotic lesions.

According to the company, the Formula 414RX device is a rapid-exchange stent system with a 0.014-inch guidewire. The Formula 418 device is an over-the-wire balloon system with a 0.018-inch guidewire. Cook Medical stated that the devices are designed to cross lesions with high pushability, trackability, and kink resistance. The low-profile design avoids shortening after deployment to allow precise placement.

In related company news, principal investigator Robert Bersin, MD, presented initial data from Cook Medical's REFORM clinical trial at the International Symposium on Endovascular Therapy in Miami Beach, Florida.

The objective of REFORM is to assess the safety and effectiveness of the company's Formula balloon-expandable renal stent for treating renal artery stenosis. One hundred patients were enrolled at seven investigative sites throughout the United States. Initial data were compiled at 9 months postprocedure and benchmarked against well-established performance data, the company noted. The data showed a 9-month primary patency rate of 91.7% and a 97% rate of successful delivery and deployment of the stent.

"The data for the REFORM clinical trial reflect the clinical performance and patency of this dedicated renal stent platform," commented Dr. Bersin. "These initial data indicate the balloon-expandable stent may offer a new treatment option for patients suffering from renal artery blockages."