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This article was originally published in The Gray Sheet

Executive Summary

HEART TECHNOLOGY'S ROTABLATOR ATHERECTOMY DEVICE FOR CORONARY USE will be launched immediately at a price of "just under" $1,000 for the disposable component of the system, the company says. Approved for coronary use on June 1, the atherectomy device will be marketed to interventional cardiologists in the U.S. by the Bellevue, Washington firm's 10-person direct sales force. The Rotablator has been marketed in the U.S. for peripheral use since 1990 and currently is marketed by distributors in Canada, Europe and Australia for peripheral and coronary applications. Initial domestic commercial sales of the rotary atherectomy device for coronary use will be to former investigational sites; training for new physicians is slated to begin in early August, according to the firm. The Rotablator system utilizes a disposable diamond-coated burr and flexible drive shaft to remove plaque in arteries. The speed of the burr, which is driven by compressed air and rotates at up to 190,000 rpm, is controlled by a separate console that lists for $6,800. The firm says in a June 2 press release that "unlike balloon angioplasty, which leaves plaque in the artery, the Rotablator device removes even difficult to treat plaque, converting it into particles generally smaller than red blood cells" that can be eliminated by the body. Rotablators for coronary applications have a shaft length of 135 cm and burr sizes ranging from 1.25 mm to 2.5 mm in diameter. For peripheral applications, the shaft length is 95 cm, and the burrs range from 1.5 mm to 4.5 mm in diameter. Heart Technology says that in a study of the coronary application involving more than 2,000 patients, "the overall success rate was 95 percent and the incidence of major complications was low, despite the wide variety of plaque types, locations and the degree of technical difficulty involved." Success was defined as "opening the artery to at least 50% of the diameter of the native artery with or without adjunctive balloon angioplasty, and no major complications." FDA is requiring Heart Technology to conduct a postapproval study following the original study cohort of 495 patients for one year post-procedure. The agency's approval letter directs that "all patients who undergo repeat angiography must be analyzed for endothelial lesions of new origin that may have been precipitated by the rotation of the burr immediately proximal and distal to the original site." Approved labeling for the Rotablator states that the device can be used as a sole therapy or with adjunctive balloon angioplasty in patients with coronary artery disease who are candidates for coronary artery bypass graft surgery. The patients should meet one of four selection criteria: "single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guidewire"; "multiple vessel coronary artery disease that in the physician's judgment does not pose undue risk to the patient"; "certain patients who have had prior percutaneous transluminal coronary angioplasty, PTCA, and who have a restenosis of the native vessel"; or "native vessel atherosclerotic coronary artery disease that is less than 25 mm in length." Labeling notes that "the restenosis rate for patients treated with the Rotablator system is not proven to be different in comparison to the restenosis rate obtained for patients treated with balloon angioplasty or other interventional devices." The Rotablator is contraindicated for use in "occlusions through which a guidewire will not pass"; the "last remaining vessel with compromised left ventricular function"; saphenous vein grafts; cases where there is "angiographic evidence of thrombus pretreatment"; and cases where there is "angiographic evidence of significant dissection at the treatment site." Approval comes nearly three years after the firm's premarket approval application submission ("The Gray Sheet" Oct. 15, 1990, p. 15). Approval was held up by manufacturing problems which resulted in a June 1992 recall of investigational coronary devices and devices marketed for peripheral use ("The Gray Sheet" Nov. 23, 1992, I&W-5). The Rotablator is the third atherectomy catheter to enter the coronary market. Interventional Technologies markets the TEC catheter, which was approved last month for coronary applications ("The Gray Sheet" May 24, p. 7), and Devices for Vascular Intervention markets the Simpson Coronary Atherocath, approved in September 1990 ("The Gray Sheet" Oct. 1, 1990, p. 18).

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