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This article was originally published in The Gray Sheet

Executive Summary

Cook will launch its Gianturco-Roubin Flex-Stent coronary stent following company-sponsored training sessions scheduled to start in mid-July. Distribution of the device, the first coronary stent to receive FDA approval, will be limited to those facilities with hospital personnel who have participated in the firm's training workshops. The company expects to conduct approximately four workshops each month at sites across the U.S., training 50-70 clinicians per session in use of the stent. The company also is encouraging nursing staff to attend the one-day training programs for instruction on pre- and post-operative treatment of patients. The need for training is highlighted in the product's labeling, which contains a boxed statement cautioning: "Use of the Gianturco-Roubin Flex-Stent coronary stent requires advanced coronary angioplasty technical skills. Mandatory attendance at an accredited stent training symposium is required before use of this device." The device was approved May 28 for use "with balloon angioplasty in patients whose heart vessels close back up or threaten to close back up during the procedure," according to FDA. In a June 2 press release, FDA Commissioner David Kessler highlights the device as "another tool to treat diseased coronary arteries," adding that the coronary stent "will be helpful for that small group of patients in whom balloon angioplasty might otherwise fail, causing heart attacks or even death." The agency estimates that between 2% and 11% of the roughly 300,000 patients who receive coronary angioplasties annually experience vessel closure or threatened closure, making the device potentially useful in 6,000 to 33,000 patients per year. Currently marketed in Australia, Korea and Singapore, Flex- Stent is comprised of an implantable stainless steel mesh coil and a compliant balloon catheter on which the coil is premounted. The device, which is intended for one-time use, is inserted via a guiding catheter "to the obstruction and anchored into the vessel wall by inflating the balloon on which it is mounted," according to the company. The stent is 20 mm long and available in five diameters, ranging from 2 to 4 mm. Cook is pricing Flex-Stent at approximately $1,150. A 10- person dedicated sales team will spearhead the marketing effort, assisted by additional reps from Cook's general sales force. The only other stent on the market for a cardiovascular indication, Johnson & Johnson's Palmaz, was approved in 1991 for use in iliac arteries of patients who have undergone a "suboptimal balloon angioplasty procedure" ("The Gray Sheet" Oct. 7, 1991, p. 3). A smaller version of the device, the Palmaz-Schatz, currently is under review at FDA for coronary applications. Approval of Flex-Stent comes approximately one year after its review by FDA's circulatory system devices panel ("The Gray Sheet" May 18, 1992, p. 12). At the May 1992 meeting, the panel voted 4-0 in favor of approval of the device on the condition that the firm revise the warning section of the product labeling and conduct postmarket studies. The company responded to the panel's recommendation for labeling modifications by adding coronary pseudoaneurysms and systemic stent embolization as "possible adverse effects" in the final product label. Also on the panel's recommendation, the company incorporated the definition of "threatened closure" used in clinical studies of the stent into its labeling. The label now states that "threatened closure is evidenced by deterioration of angiographic, hemodynamic or clinical indicators from baseline values," followed by a description of such indicators. The panel's request for postmarket studies is reflected in two conditions outlined in FDA's approval letter. FDA says that the company must "provide six-month followup information on an initial cohort of 75 patients having undergone stenting of a saphenous vein graft and who are classified as initial establish the long-term effects of the device in saphenous vein bypass grafts." The agency also is requiring the firm to provide followup on at "least a yearly basis" of patients who develop a coronary pseudoaneurysm. This information, FDA says, "is required to establish the ultimate fate of arteries in which this complication manifests itself."

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