VisionCare’s implantable telescope for patients with advanced macular degeneration was FDA approved in August. Since then, little information has been available, but I received an update from the company last week.
Though FDA approval has been received, VisionCare, the parent company, has not started shipping this implantable device. The company is quite small and is gearing up for market release. Reading between the lines, this may occur in the next 6 months.
In simplest terms, Medicare has yet to approve this device for insurance coverage, that is, they haven’t agreed to pay for it yet. The parent company must submit an application based upon the FDA approval and the fact that this is a brand new type of medical device.
Obviously, VisionCare isn’t going to ship the Centrasight telescope if it isn’t going to be covered by insurance.
If you read my last article regarding the CentraSight, the implantation of the telescope involves a team approach and, thus, training for all the eye professionals involved. Training will be required for the surgeons, eye doctors, nurses, technicians, etc.
The company is hopeful to start the initial “launch” at the centers involved in the clinical trials. Additional sites and doctors will be added as time goes on. My own practice is hopeful to be one of the first to train.
Additional information has been provided on the CentraSite web page.
What Does This Mean? At the very least, the telescope will have limited availability for the first half of the year. Without Medicare approval, the device simply won’t be marketed. The development of other centers for the device to be implanted will depend upon the initial revenues and popularity of the device. This is not unlike cell phone coverage.
The CentraSight telescope is also a good example of how the FDA and Medicare together to bring devices to market. FDA approval doesn’t mean Medicare’s endorsement as the two operate independently.
Overall, there are many variables to watch; the speed or rate in which new centers are developed and new doctors trained and the fiscal issue of insurance payment. Be patient.