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ENDOSONICS INITIATES TRANSPORT PTCA/DRUG DELIVERY CATHETER CLINICALS

This article was originally published in The Gray Sheet

Executive Summary

ENDOSONICS INITIATES TRANSPORT PTCA/DRUG DELIVERY CATHETER CLINICALS on July 14 with the treatment of the first patient at Scripps Memorial Hospital in San Diego. Under an investigational device exemption (IDE) approved by FDA on June 11, the firm has clearance to test Transport in 50 patients at five sites. The device performs balloon percutaneous transluminal coronary angioplasty and delivers drugs "directly to the site of the PTCA" to "treat the blockages caused by both the atherosclerotic plaque and the thrombus," according to the firm. Transport is an angioplasty catheter with a porous membrane over the balloon. During an angioplasty procedure, a user can introduce drugs between the balloon and the membrane; the drugs then pass through the membrane to the angioplasty site. Under the IDE, the device may be used for intracoronary PTCA with urokinase, a thrombolytic which dissolves blood clots within arterial plaque. The population for the study includes patients with complications from angina, stent implantation or post myocardial infarction. Results of the trials will be used to support a premarket approval application. Pleasanton, California-based Endosonics hopes to be the first firm to sell a single device to perform both PTCA and drug delivery. The company estimates Transport's potential market at about 25% to 30% of the total PTCA market, "or over 125,000 patients annually," according to a July 15 press release. Endosonics is planning to launch the device in Germany and France in the fourth quarter. Clinicals conducted in Europe during the past year have produced "successful results," the firm says. A Japanese market launch is targeted for 1994. Endosonics is in the process of seeking regulatory approval in the three countries. Transport was developed by Endosonics' wholly owned subsidiary Cardiovascular Dynamics. Endosonics' acquisition of Cardiovascular Dynamics became final on July 14. A letter of intent to acquire the 67% of the privately held firm that Endosonics did not already own was signed in April ("The Gray Sheet" May 17, p. 4). Endosonics had acquired a 33% stake in CVD in June 1992 in an agreement that gave the firm international distribution rights to CVD's technologies ("The Gray Sheet" July 6, 1992, In Brief). Under the final terms of the recent deal, Endosonics paid $335,000 in cash and 289,819 shares of its common stock for the outstanding shares of CVD, making the deal worth roughly $2.2 mil. based on Endosonics' July 13 closing price of $6.50 per share. "An additional 50,000 shares of Endosonics stock may be paid to CVD shareholders contingent upon the completion of certain events within the next two years," according to Endosonics. The company says it plans to take an accounting charge in the second quarter 1993 for expenses related to the recent "purchase and integration of CVD into Endosonics." In addition to the Transport catheter, CVD products in development include the Bullett drug delivery catheter and the Periflow infusion catheter; 510(k) submissions have been made with FDA for both devices, according to Endosonics.

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