CDRH PROMO UNTITLED LETTERS.

The following untitled letters are the first in a series issued by the Promotion and Advertising Staff of the Center for Devices, Office of Compliance (CDRH-OC) in 2001. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval.

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Advanced Cosmetic Laser Center/The Professional Center at Woodmont, Tamarac, FL, Jan. 18, 2001 (CDRH-OC). FDA wrote that the firm's Web site included information about the use of medical-grade silicone for wrinkle reduction and filling of acne scar depressions and advised that the only approved use was for treatment of detached retinas. PMA, Web

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Alcon Research, Ft. Worth, TX, Feb. 20, 2001 (CDRH-OC). The agency stated that Alcon's Web site promoting the LADAR excimer laser system claimed that 66% of nearsighted patients with astigmatism achieved 20/20 vision or better and insisted that the figure should be 64%. Regarding nearsighted patients with astigmatism, the agency stated that the claim that 54% achieved 20/20 or better should be 50%. Web

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Arrow International, Reading, PA, Feb. 13, 2001 (CDRH-OC). The letter stated that a company representative had sent promotional materials to a physician deemed violative due to claims that the firm's model 8472 infusion pump was "the least expensive, safest and smallest infusion pump available." FDA insisted the firm had no data to support the claim.

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Burnshield, Ltd., Wadeville, South Africa, March 9, 2001 (CDRH-OC). The letter cited the firm for continued claims on its Web site that its trauma dressing had antibacterial effects, noting that the claim of bacteriostasis was allowed. PMA, Web

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CIBA Vision, Duluth, GA, Feb. 21, 2001 (CDRH-OC). FDA recommended the firm amend its verbiage for any ads or promotional material for the MemoryLens intraocular lens to include the note that the device was for correction of aphakia "in patients sixty years of age and older" suffering from catarctous lenses.

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Dornier Medical Systems, Kennesaw, GA, March 14, 2001 (CDRH-OC). The letter stated that the firm's Web site listed an investigational new device, the EPOS Ultra, and that the Web page contained hidden terms which were visible when the page was highlighted or printed out. FDA insisted that the terms linked the device to uses not approved in the U.S., including treatment of skin cancer, secondary cataracts and botox (botulinum toxin). Web

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The Eye Clinic of Texas, League City, TX, Jan. 23, 2001 (CDRH-OC). In addressing the Eye Clinic's promotion of the Autonomous LADAR Vision excimer laser in the "Houston Chronicle," the agency stated that the device was restricted and that it required promotional materials to "include a standardized statement of intended uses and relevant warnings, precautions, side effects and contraindications."

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Ira Freilich, M.D., Altamonte Springs, FL, Jan. 29, 2001 (CDRH-OC). FDA noted that the physician used liquid silicone for cosmetic uses and warned Freilich that the substance could not be promoted for uses other than for treatment of detached retinas. PMA

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Hermann Eye Center, Houston, TX, Jan. 23, 2001 (CDRH-OC). Regarding the clinic's promotion of the Autonomous LADAR Vision excimer laser, the letter noted that the device was restricted and that FDA expected that such promotional materials would "include a standardized statement of intended uses and relevant warnings, precautions, side effects and contraindications."

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Hermann Eye Center, Houston, TX, Jan. 23, 2001 (CDRH-OC). FDA addressed the clinic's Feb. 6, 2001, response to the Jan. 23 letter and commented that referring patients to product labeling was no substitute for required information regarding warnings, precautions, side effects and contraindications.

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Interventional Technologies, Inc., San Diego, CA, Jan. 4, 2001 (CDRH-OC). FDA cited the firm's promotion of the Cutting Balloon, a device for percutaneous transluminal coronary angioplasty indicated for dilation of stenoses to improve myocardial perfusion, for failure to distinguish between peer-reviewed journal articles versus presentations and abstracts. The agency added that the promotional pieces lacked information on contraindications and adverse effects. The letter did not indicate the date of FDA's review of the promotional pieces.

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Marconi Medical Systems, Cleveland, OH, Feb. 20, 2001 (CDRH-OC). The letter requested an update on the 510(k) status of the Mx8000 CT system which the agency believed had been previously cleared under the name Volumax.

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Mallinckrodt Medical, Hazelwood, MO, Jan. 19, 2001 (CDRH-OC). FDA cited the firm's Web site and a journal ad for promoting the DAR series of sterivent breathing filters with claims that the devices could protect against hepatitis C, HIV and tuberculosis. The warning letter indicated that the claims constituted a major modification of intended use. PMA, Web

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Pharmacia, Peapack, NJ, Feb. 9, 2001 (CDRH-OC). The agency cited Pharmacia for failure to include information on intended uses and relevant warnings and contraindications in journal ads for Healon GV and Healon V.

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St. Jude Medical, Minnetonka, MN, March 14, 2001 (CDRH-OC). The letter stated that an undescribed promotional piece for the AngioSeal hemostatic puncture closure device compared the device to the Closer, manufactured by Perclose, and FDA inquired as to the rationale behind employing IFUs, a term FDA did not define, in making the comparison. The agency stated further that such comparisons were only permitted after head-to-head clinical studies.

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TLC Laser Eye Centers, Bethesda, MD, Jan. 30, 2001 (CDRH-OC). FDA blasted the company for continued promotion via the Web of the VISX Star S2 excimer laser for treatment of hyperopia, commenting that a disclaimer indicating the agency had not approved of such use was not mitigating. PMA, Web

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Toshiba America Medical Systems, Tustin, CA, Feb. 20, 2001 (CDRH-OC). FDA stated that the firm's claim that its Aquilion line of CT scanners "can perform or measure coronary artery calcium scoring and can be used on asymptomatic patients" was violative because it failed to note that the procedure required the use of the Vital Images VScore, a device of undescribed function. PMA, Web

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Westhaim Biomedical, Exeter, NH, March 13, 2001 (CDRH-OC). The agency stated that the use of the word "healing" in describing the firm's Acticoat line of wound dressing suggested a curative function and recommended the use of alternate language. FDA inquired as to the effect of silver on wounds given the cytotoxic nature of the substance.