February 2007 Issues

Orthopedic Update

Summary: Compared to 2006, surgeons expect total knee replacements this year to be up 12% and hip replacements up 8%. ♦ Zimmer’s Gender Solutions Knee for women is viewed by many surgeons – Zimmer customers as well as noncustomers – as mostly marketing hype, but it is resonating with women, who are asking their doctors about it. Most Zimmer doctors are switching to it almost 100% for women (and even a few men), from whatever Zimmer implant they were currently using, even though it is a premium over Zimmer’s NexGen Hi-Flex, but it isn’t converting many non-Zimmer users. ♦ Hospitals are more price conscious than a year ago, but surgeons said that is not causing any shifts in the brands or numbers of implants they are using, and they expect vendors to be able to raise prices 3%-5% this year. ♦ Hip resurfacing is expanding the market, bringing in new, younger patients who are not eligible for a total hip replacement, and private payors are covering it, usually at a markup to an implant procedure. The surgery is complex, with many doctors taking a wait-and-see approach, but it is catching on. ♦ Implants made of metal-on-metal and highly cross-linked polyethylene each have proponents, but use of ceramic-on-ceramic is continuing to fall due to fractures and squeaking.

Eye Care Update

Summary: Glaucoma. Sales of prostaglandins have flattened. Interest is high in neuroprotective agents, but as adjunctive therapy, not monotherapy, and insurance coverage and price will dictate use. ♦ Dry eye. Use of Allergan’s Restasis is low and unlikely to increase much unless the price is lowered, though more samples for optometrists and a continuation of direct-to-consumer advertising may help. ♦ Contact lenses. CooperVision’s silicone hydrogel lens is not expected to be launched until perhaps September 2007, and Johnson & Johnson/Vistakon appears to be picking up quite a bit of business in the wake of Novartis/Ciba Vision’s recall of some O2Optix lenses. ♦ Contact lens solutions. Corneal staining is getting increasing attention, and it appears to be due to a mis-match of lenses and solutions, with the most problematic Bausch & Lomb’s ReNu and the least Alcon’s Opti-Free, but this is not confirmed yet. ♦ Multifocal IOLs. Interest is increasing, especially for cataract patients but also for refractive lens exchange. ♦ Refractive surgery. The market is maturing and flattening, with price, contact lens improvements, patient fears, and the economy all playing a role. In addition, many patients – especially presbyopes – want more than LASIK can deliver, but presbyopic LASIK is not yet ready for prime time.

FDA Panel Dubious about Devices for Treatment-Resistant Depression – and CMS Rejects Coverage of One Device -- Quick Pulse

Summary: The FDA’s Neurological Devices panel of the Medical Devices Advisory Committee met in Gaithersburg , MD , January 26, 2007 , and it was a difficult day for three device companies: Neuronetics, Cyberonics, and Confluent Surgical.