17 Nov Update on Implantable CentraSight Telescope
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.
Telescope is Not Being Shipped
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.
Training Centers for Eye Doctors
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.
Information for Patients
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.
J P HickeyPosted at 14:56h, 17 November
This is great news. We hope that the Medicare approval will occur without delay..
Dick MarquisPosted at 21:30h, 17 November
If I recall your previous writeup on this device, it is not an appropriate treatment for those who have had cataract surgery. Is this still true?
Randall V. Wong, M.D.Posted at 08:43h, 18 November
For now, this is still true, but it doesn’t make great sense to me. It was probably part of the study protocol. I bet if we wait a while, after the product hits the market, that criteria will change, unless there is reason an implant physically alters the eye to prevent placement of the device.
Doug StephensPosted at 17:12h, 18 November
Dear Dr. Wong:
When the natural lens is removed and replaced by the telescope, is the procedure non-reversible?
In other words, if something better comes along, such as stem cell treatment can the lens be replaced with an artificial one?
Randall V. Wong, M.D.Posted at 18:22h, 18 November
I am quite sure that it will be reversible, that is, it can be taken out. We’ll see. Keep your fingers crossed.
DoddannawarPosted at 17:26h, 05 December
Dear Dr. Wong,
I have no medical insurance and would like to understand the cost of the procedure. While I realize this is a difficult question to answer without knowing the patients history and is different for each individual, a ball park estimate would be appreciated which will help me figure out if I can afford the treatment on my own. Also, where can I find a list of Centrasight Treatment facilities. I am located in Michigan and would like to find the closest treatment facility.
Randall V. Wong, M.D.Posted at 14:10h, 07 December
I am including the website for your review. To date, no sites have been established to implant the telescope. It is anticipated that the initial sites will be those practices that were involved in the original study.
I also do not know of the cost of the CentraSight. I am sure this will be related to the insurance reimbursement.
Best of luck. I hope that this is somewhat helpful. Feel free to check back with us to check our status!
JaflosaPosted at 22:19h, 03 January
I am 53 with cone dystrophy MD. Do you think the age citeria will remain 75. I have been waiting for the product for some time I even changed sities to get into the clinical trail, but was later refused because of my age. I feel as if I am running against the clock because I have been a registered nurse for over 30 years , but I recently retired because I did not feel that my patients were confidnet in my abilities although I use adaptive equipment that bring my vision to near normal. The device would really allow me to pracitce without alarming my patients.
Randall V. Wong, M.D.Posted at 23:08h, 09 January
I am guessing that as the telescope becomes more popular several things will happen;
1. Other devices will follow.
3. “off-label” indications will certainly come in play.
Stay tuned and keep in touch.
jan PattersonPosted at 22:59h, 07 January
Please keep me on your email list if this becomes accepted by Medicare. My husband has dealt with Advanced Macular for over 10 years now.
It would be wonderful if some vision would help him to be able to enjoy the rest of his life path.
Thank you for the research you have performed so far.
Randall V. Wong, M.D.Posted at 23:21h, 09 January
I will keep the blog updated and encourage you to subscribe. This will ensure you don’t miss any news regarding the telescope.
By the way, I took the liberty of removing your cell number from the post.
Stay in touch!
JoAnne JuettPosted at 08:46h, 30 January
Thank you so much for providing a place for continuing information about this implant. My mother has been screened by her low vision specialist and her information submitted, but we haven’t heard a thing since. Of course, the longer Medicare waits, the older and less eligible these patients become! We are ready to fly wherever it takes to get the procedure done once we hear about Medicare approval and know the next steps to take. Please keep me on your list so that we can know when this happens. We are very excited–she has had macular degeneration for 20 years now.
Randall V. Wong, M.D.Posted at 11:15h, 30 January
Dear Ms. Juett,
We, too, haven’t heard a thing from the company. They did respond to our initial inquiry about 2 months ago, but haven’t heard a peep since then.
Roxanne DeJames, RN,BSN,CRNIPosted at 17:22h, 18 February
I have been in email contact with the company prior to and since FDA approval. My Father has AMD, quite advanced now, and has been on their “list” since the time of approval. He is completely healthy except for the loss of central vision. This is causing depression, as he has never been dependent on anyone and has always been a voracious reader. My family has offered to pay cash and travel wherever necessary to obtain this device for our father. The company,Centrasight, has been answering my emails, but, as you noted, apparently Medicare must approve first. If this becomes available to you in the future, would you be so kind as to contact me? Time is moving on and I fear that if the depression gets too entrenched, or balance/falls becomes an issue, we might not have dad around!
Randall V. Wong, M.D.Posted at 20:01h, 19 February
I wish I could offer some sort of promise, but this Centrasight marketing is baffling. I will absolutely do my best to contact you if we start inserting the telescope. I would suggest you watch the email updates closely as this is something I definitely will be “watching.”
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sarah greenPosted at 08:09h, 21 December
Has the CentraSight Telescope been approved for patients with Histoplasmosis? I am currently legally blind in left eye(no central vision) and my right(good) eye became active two years ago and I have been receiving Lucentis injections of and on these last two years. As of now I still have fairly good central vision in my right eye but am very concerned about the future due to the new occurances.
Randall V. Wong, M.D.Posted at 14:20h, 21 December
I am so sorry to hear about both eyes now involved. CentraSight is not approved for OHS as far as I know.