SPECTRANETICS CVX-300 EXCIMER LASER SALES BEGIN FOLLOWING FDA APPROVAL FOR USE IN CORONARY ARTERIES; FIRM WILL TAKE OVER EUROPEAN SALES AND DISTRIBUTION

Spectranetics began shipments of its CVX-300 excimer laser coronary angioplasty system on Feb. 22, the day FDA granted approval of the device. Spectranetics will market the system domestically through its seven-member direct sales force, which is supported by six clinical representatives ("The Gray Sheet" Nov. 16, p. 10). At $250,000, Spectranetics' laser is priced comparably to the only other FDA-approved coronary excimer laser, Advanced Interventional Systems' Dymer 200+. Disposable catheters, which Spectranetics developed for use in conjunction with the CVX-300, will sell for between $800 and $900 each. The catheters are available in 1.4 mm and 1.7 mm sizes. Spectranetics plans to assume direct responsibility for overseas product sales in May after the expiration of a three-year exclusive marketing agreement with Medtronic, which helped develop the laser system ("The Gray Sheet" May 21, 1990, p. 5). The company will market its products overseas through a new subsidiary, Spectranetics International B.V., which will use a direct sales force and distributors. Most of the firm's 26 lasers in Europe have been placed in Germany and France. Spectranetics also is finalizing sales relationships with independent dealers in 11 far eastern countries, including Japan and Australia. In preparation for sales of the CVX-300, Spectranetics recently negotiated with Pillco Limited Partnership a non- exclusive license to Pillco laser angioplasty patents. The agreement includes a cash payment to cover royalties due on prior overseas sales of the CVX-300. Pillco signed a similar agreement in January with AIS ("The Gray Sheet" Jan. 18, In Brief). FDA has approved the CVX-300 for six indications: saphenous vein grafts ** lesions that are 20 mm or greater ** balloon angioplasty failures ** total occlusions crossable by a wire ** ostial lesions ** and moderately calcified lesions. In a Feb. 22 release, Spectranetics claims that the range of indications covered under the approval is "the broadest issued to date" by FDA because the Dymer 200+ is approved only for lesions that are 20 mm or greater. Spectranetics notes that "industry experts estimate that each year as many as 200,000 patients currently treated with balloon angioplasty alone, or with coronary bypass surgery, could benefit from this new laser treatment." FDA approval of Spectranetics's laser comes two years after the company submitted a premarket approval application for the device to FDA and a year-and-a-half after FDA's circulatory system devices panel recommended approval pending several labeling changes ("The Gray Sheet" Dec. 2, 1991, p. 4). The requested labeling changes were submitted to FDA on Nov. 12, 1992. The company also altered, at FDA's request, the indication regarding lesion size to 20 mm or greater from 10 mm. Spectranetics says that it is currently collecting clinical data to support a PMA application for peripheral indications of the laser.