Healthcare Industry News:  Cook 

Devices Interventional

 News Release - March 19, 2008

Cook Medical Announces the Launch and First Patient Enrollment of the REFORM Clinical Trial

U.S. Trial Designed to Evaluate Treatment of Renal Artery Stenosis via Stenting

BLOOMINGTON, Ind.--(HSMN NewsFeed)--The U.S. Food and Drug Administration (FDA) has approved initiation of the REFORM clinical trial, officials of Cook Medical announced today. The REFORM trial is designed 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 if left untreated.

The trial’s primary purpose is to evaluate the safety and effectiveness of the Formula Balloon Expandable Stent for the treatment of renal artery atherosclerosis against well-established performance data. The trial will enroll up to 100 patients at up to 30 investigative sites through the U.S. and initial results are expected to be available in Q2 of 2010.

The trial’s first patient is undergoing treatment from the national principal investigator Dr. Rajesh M. Dave, chairman of Endovascular Medicine at Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital in Harrisburg, PA.

“I am particularly impressed with the very low profile of the Formula stent and its ability to cross the stenosed renal arteries of my patients," said Dr. Dave. “The stent system also 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."

Cook Medical’s 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 an extremely low profile that is lower than many cobalt chromium stent platforms. In addition, the stent does not shorten upon expansion, which can potentially improve accurate placement across the diseased lesion. The Formula 418 stent also features an increased number of stent crowns improving stent circularity, which may improve wall apposition of the stent to the renal artery.

“We are pleased that the FDA has given us approval to conduct this important clinical trial, and that our first patient has been enrolled in the study,” said Rob Lyles, global leader of Cook Medical’s Peripheral Intervention products division. “This study will give us an excellent opportunity to characterize the impact of the Formula Balloon Expandable Stent on renal artery revascularization and related clinical outcomes. We are optimistic that this stent will help patients in the battle against renal artery stenosis thus improving their quality of life.”

The Formula Balloon Expandable Stent is an investigational device and not currently indicated for renal artery stenosis in the United States.

About Cook Medical:

Cook Medical was one of the first companies to introduce interventional devices in the United States. Today, the company participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes. Cook won the prestigious Medical Device Manufacturer of the Year for 2006 from Medical Device and Diagnostic Industry magazine. For more information, visit www.Cookmedical.com.


Source: Cook Medical

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