Boston Scientific wins FDA approval for penile prosthesis pump

[wilsonmill]

Boston Scientific (NYSE: BSX)+
announced that the FDA granted approval for its Tenacio pump component for its AMS 700 inflatable penile prosthesis (IPP).
This was a article released 16Nov2023,
According to Boston Scientific, the company engineered the pump to address unmet user needs related to pump reliability. It designed Tenacio to maximize reliability across repeated use and achieve a more streamlined inflation experience. Dedicated valve systems perform independent functions to help address stiction syndrome (otherwise known as sticky pump).
The system features a prominent grip design, elongated pump neck and a high-profile, one-press release deflation button.
Boston Scientific President of Urology, Meghan Scanlon, said the system’s design may help shorten the patient learning curve. In a LinkedIn post, she called it a win-win for patients and their doctors.”

Has anyone had this pump installed with their AMS700?

[Gt1956]

I would expect that until the companies works through their existing inventory. The only patients to get them will be if they or their dr requests them.

The value of the floating stock has to be a pretty huge sum. Likey too large of sum to just dispose of all the old models.

[Tmansdorfer]

I had a revision in January and was under the impression I was getting the new pump since it was FDA approved but come to find out they haven’t released it to the market to be used. My surgeon told me it would probably be toward the end of this year before they will be available for use.

[wilsonmill]

Well I guess the original one wasn't so bad then if they are waiting a year to release to the market. AMS may be the option I will go with for my revision if the Dr says it is ok. Still waiting to see them.

[frank66665]

I think they made some small changes to improve it. essentially it will be the same as 90%, I think it's worth taking in case of an overhaul or new system

[wilsonmill]

There are some posts that complain about the hardness of the AMS pump, that it's hard to mash, maybe that's what they worked on

[LastHope]

IPP and reliability are like oil and water. When companies make efforts to marry those two, I applaud them.

[DeadlineDave]

I spoke with the patient advocate on the Boston Scientific phone line yesterday.

She said the pump has been released to a select group of surgeons, but is not yet widely available. Also, she said she didn't believe this new pump could be "swapped out" for the old-style pump without a revision of the entire system. I was curious since I think I may be getting my pumped moved.

She also told me something that didn't make sense: Occasionally, when I'm up in the 25 pump territory and I can't get any more in, the bulb goes soft and seems to expand and contract very easily. I don't think any fluid is being pumped at that time. She said that meant my cylinders were full and could not take any more fluid, which just seems wrong to me.... it seems the bulb at that point would be so hard you couldn't squeeze it anymore. The LGX expands.....I'm no where near 25% expanded. Also, if I release a little fluid and start pumping again, the bulb is very hard like it was on the last of the initial 25 pumps.

[2435tjklAS]

She also told me something that didn't make sense: Occasionally, when I'm up in the 25 pump territory and I can't get any more in, the bulb goes soft and seems to expand and contract very easily. I don't think any fluid is being pumped at that time. She said that meant my cylinders were full and could not take any more fluid, which just seems wrong to me.... it seems the bulb at that point would be so hard you couldn't squeeze it anymore. The LGX expands.....I'm no where near 25% expanded. Also, if I release a little fluid and start pumping again, the bulb is very hard like it was on the last of the initial 25 pumps.

I think this might be a result of you being about four months out. I know it as what my Boston Scientific liaison called the bypass valve. It's that almost all men would probably attempt to overpump the implant to make it as big as possible and that could cause some problems, so the backup valve was created to make it deflate a small amount when you get over the max pumps.

I seem to remember when I was recovering about it getting very hard like that, but at this point when I over-pump it just gets softer and I can tell my inflation amount is a little less.

[wilsonmill]

Makes sense, valve reduces pressure on implant if the pressure gets to high. I had a Titan and I would pump it till you couldn't get another squeeze in. Over pressure is what probably burst the tubing or at the connection point. I will be talking to Dr about using the AMS lgx with the new pump. Maybe they have worked the bugs out.