October 2007 Issues

LASIK Update -- Quick Pulse

Summary: Thirteen refractive surgeons and the CEO of a refractive surgery company with multiple centers were interviewed to get a look at LASIK volume for the second half of 2007. ♦ On average, these doctors estimated that LASIK procedure volume was down 5% 3Q07 compared to the same time last year, but without one surgeon who reported a 50% drop in business, procedure volume was flat vs. 3Q06.

FDA Panel Gives Thumbs Up to Medtronic's Endeavor Drug-Eluting Stent

Summary: The FDA Circulatory System Devices Advisory Committee has recommended unanimously that Medtronic’s secondgeneration drug-eluting stent be approved. ♦ However, the panel attached two conditions to approval: 1) Changes to the postmarketing plan to make it larger and more rigorous, and 2) Give it the same label language on dual antiplatelet use as other drug-eluting stents. ♦ The bottom line is that Endeavor is likely to get approved but should not have a more favorable label than Johnson & Johnson’s Cypher or Boston Scientific’s Taxus. ♦ The stent thrombosis rate with Endeavor in the ENDEAVOR-IV trial was 0.8%, with 3 stent thromboses in the first 30 days and another 3 between 1 and 6 months, but none after that – yet.

Silicone Breast Implant Update -- Quick Pulse

Summary: To check on how quickly silicone breast implants are catching on since the FDA lifted restrictions on them in November 2006, 14 surgeons were interviewed. On average, 55% of new breast implants put in by these doctors are now silicone, and the percentage is expected to continue to increase to 60% over the next 6-12 months, reaching 76% at peak. ♦ Few women are switching out saline implants for silicone, and the new “gummy bear” implants in development are getting mixed predictions for uptake. ♦ No significant brand shifting appears to be going on, and overall implant volume is relatively flat, with no real signs that the economy is causing a decline in cosmetic procedures like this.

The Family Medicine Perspective -- Quick Pulse

Summary: Family medicine doctors often write more prescriptions for particular medicines than their specialist counterparts, so understanding their attitudes toward a variety of topics and their clinical practices are very important in determining the outlook for new drugs and devices as well as expanded labels for existing products. ♦ The American Academy of Family Practice (AAFP) annual meeting in Chicago from October 4-6, 2007 , was attended by more than 5,000 family doctors, and 62 of them (yes, 62 – an interviewing marathon) were questioned on a number of issues, from cholesterol and diabetes medications to the human papillomavirus (HPV) vaccine and drugs to treat hypertension, gastrointestinal disorders, arthritis, and allergies, etc. ♦ They were also asked about managed care issues and electronic prescribing (e-prescribing).

American Urogynecologic Society

Summary: Doctors are increasingly preferring transobturator slings to TVT slings. Minislings are seen as interesting but still very experimental. The prediction is that if they pan out, they will capture the market. ♦ Off-label use of Allergan’s Botox to treat refractory urge incontinence is picking up. The question is whether to use it before or after neurostimulation, but it is a potentially significant threat to Medtronic’s InterStim, especially if it gains FDA approval for this indication and the currently spotty reimbursement improves. ♦ Hospitals with one of Intutive Surgical’s da Vinci robots are buying additional robots, and academic centers without a robot are getting one – mostly for urology but also to share with gynecology, in particular. Other hospitals without a robot do not feel competitive pressure to have one. Yet, interest in robots for GYN procedures is definitely growing, and GYN is helping to justify purchases of first, second, and third robots.