Boston Scientific Corporation
11/22/2024 | Press release | Distributed by Public on 11/22/2024 17:25
A groundbreaking advance in treating erectile dysfunction: the TENACIO™ Pump
For as long as erectile dysfunction (ED) has existed, there have been people determined to find a solution.
In the 8th century BC, for instance, if you were unable to attain or maintain an erection, you might be treated with herbs or prayer.
By the 1930s, the first penile prosthesis designed to assist with intercourse had been created. (It was made from a rib.)
Finally, in the 1970s, came a game-changing advance: the inflatable penile implant. Kory Hamel, a director of research and development for Urology at Boston Scientific, has worked on several iterations of that original device, including the latest innovation: the TENACIO™ Pump, a new component for the AMS 700™ Inflatable Penile Prosthesis. We sat down with Hamel to learn how the penile prosthesis has evolved over the past 50-plus years, and why the TENACIO pump is designed to be the most intuitive inflatable penile prosthesis pump yet.
Why was the AMS 700 penile implant originally designed?
Designed to closely mimic a natural erection and allow for spontaneity, the AMS 700 was created to give people the ability to inflate the implant (creating an erection) and then deflate it at their discretion.
From a societal perspective, there were taboos associated with ED. But as more people were living longer and wanting to sustain quality of life during their later years, more companies and inventors began creating penile implants. It speaks to how widespread a problem ED is. There have been a lot of innovations on the penile prosthetics product line since then.
How does the device work?
The AMS 700 penile implant consists of three components implanted into the body and connected by tubing: a fluid-filled reservoir, two cylinders that sit in the penis and a pump placed in the scrotum. Squeezing and releasing the pump moves saline fluid from the reservoir into the cylinders, creating an erection. The saline fluid returns to the reservoir with a press of the deflation button.
How does the AMS 700 fit into the landscape of ED treatment options?
As an implanted medical device, the AMS 700 is more invasive than other treatment options, such as oral medications and hormone therapy. But a treatment that can work for some patients with ED may not work for others. If less-invasive therapies aren't effective, then vacuum devices, penile injections or surgically implanted devices like the AMS 700 can be a vital option.
Recently, Boston Scientific unveiled a new component for the AMS 700: the TENACIO pump. What prompted this innovation?
When Boston Scientific talked to patients and physicians, we received feedback about challenges with the device that center around the pump.
Since the pump is implanted inside the scrotum, one reoccurring challenge for patients was identifying the different pump bulb grips necessary to inflate and deflate the device. Another challenge was getting the pump to inflate the device after long periods of inactivity.
What were some of the research insights that found their way into the TENACIO pump?
As part of the development process, Boston Scientific went to patients with a model of the TENACIO pump and asked them how they thought they should use it. Most of us engineers would squeeze it hard in front of the body at chest level. But since the pump sits between the legs, we weren't getting a full understanding of the typical inflation method.
We saw a great variety of ways that people pressed the pump. Sometimes they were squeezing at the bottom, sometimes at the top. In some cases, people were not even squeezing the pump -- they're squeezing some other part of the device. Since patients operate the pump through the outside of their bodies, they need to be able to really feel it. This helped us identify the need to design a pump intended to impact overall usability for the typical patient, who is in his 50s or 60s and may not have the dexterity he once had.
As a result, some of the grips on the TENACIO pump are exaggerated to help improve ease of use. We created an elongated neck between the deflation and inflation buttons to help people distinguish between them.
TENACIO is also designed with independent valve systems to help with pump activation regardless of how fast or slow someone is squeezing it.
You and your team have obviously put so much work into this product. What kept you all motivated during the years it took to bring it to the market?
The patients who get this product have made a huge commitment to undergo an elective surgery. Since ED can take a significant toll on a patient's mental health, you know that they've suffered. It was very important for us to try to make the best possible product so it can help improve their quality of life.
Visit EDCure.com for more information on ED and our penile prostheses technology, including important risk information for the AMS 700.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
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