MINNTECH CATHETRON PTCA CATHETER REPROCESSING MACHINE

MINNTECH CATHETRON PTCA CATHETER REPROCESSING MACHINE will be launched in Europe on Aug. 29, the company reported at the 1993 Piper Jaffray Conference in Minneapolis. The firm says it could submit a 510(k) or a premarket approval application to FDA for U.S. sales of the device "as early as this fall." To use the Cathetron, the operator places the catheters into a cassette holding a disposable tray and inserts the cassette into the machine. The machine sterilizes the instruments automatically. "Push go," President and CEO Louis Cosentino explained to investors, "and 30 minutes later, the catheter is ready to use on the next patient." Sterilized catheters may be stored "for a number of days" or used immediately. "Catheters are identified during the reprocessing with a serial number" attached to the device's proximal end, so users "can keep track" of the number of reuses. The company recommends reusing catheters five times. Minntech says it has validated Cathetron for use with several Advanced Cardiovascular Systems catheters and will list those catheters on the sterilizer's instructions for use. In addition, Minntech is developing Minncath rapid-exchange and over-the- wire catheters for use with the reprocessor, and may submit premarket approval applications for the devices to FDA this fall. The Cathetron is designed to be used with Minntech's proprietary peracetic acid-based sterilant, CATHx. The firm notes that the solution must be cleared for marketing by both FDA and the Environmental Protection Agency. EPA clearance currently is pending. Minntech expects "moderate growth in the first half" (year ending March 31), Cosentino says, and "very strong growth in the second half as new products hit the market." Cosentino informed investors that "the concept of reuse is very well accepted in the European market." In 1991, he says, European catheter reutilization totalled about 80,000 cases, or roughly 40% of the total European catheter market. Minntech notes that all sterilization now is manual and that the European market for an automatic sterilizer such as Cathetron potentially is $10-$12 mil. If world reutilization matched European rates, Cosentino estimates, the catheter sterilization market would be worth about $27 mil. Minntech hopes to bring nine new products to the U.S. market this year: three sizes each of the Primus dialyzer, the Hemocor hemoconcentrator, and the Renaflo hemofilter. Based on a 14- month 510(k) clearance cycle, the firm expects August or September clearances for the devices. Minntech is encouraged by recent developments at FDA that 510(k) reviews will quicken. Referring to Center for Devices and Radiological Health Director Bruce Burlington, Cosentino remarked, "he is committed to reducing 510(k) evaluation times." The Minntech exec further noted that "we're already starting to see some progress in that area and expect approval of our products in the next three months." Last October, FDA mandated that Minntech ensure that all its Renalin dialyzer customers were using the device according to product label directions ("The Gray Sheet" Oct. 19, 1992, p. 3). Minntech says that all required customer training has been completed and the firm has on file certification from all customers that they are using the device as instructed.