Abstract
On June 22, 2010, the first femtosecond laser, InstaLase FS Laser (FS60), was approved in Japan. FS60 was developed by IntraLase Corp. (current Abbott Medical Optics, Inc.) in the U.S. The indication of FS60 is LASIK flap creation and keratoplasty, and was approved by the FDA in 2006. The principle is “Photodisruption”, in which a near-infrared laser continuously creates voids in corneal stroma.
Although FS60 was a brand new medical device in Japan, we received approval without conducting clinical trials in Japan. Instead, we introduced the clinical evaluation approach in the PMDA' consultation meeting.
On February 8, 2011, the second femtosecond laser, iFS, was also approved. In addition, iFS upgrading was approved in June which allowed us to upgrade existing FS60 units to iFS onsite. Although femtosecond laser keratoplasty is promising better clinical outcome, physicians have to overcome their hurdles such as purchase expense of the equipment and cost of essential maintenance. Reimbursement fee must include these costs.
For whatever reason, FS60 is an example of device lag. Nowadays, device lag is the most urgent issue that should be solved. Consequently, I would like to share the recent survey results of device lag and the attempt at speeding the review.
