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More minimally invasive treatments are being developed to manage benign prostatic hyperplasia, including the new Zenflow Spring System. This is a novel investigational device implanted transurethrally into the prosthetic urethra with the unique capability to be removed safely.
In a recent study, presented at the 2021 American Urological Association Annual Meeting,1 Peter Chin, MD, and co-authors assessed the efficacy of this new technology in treating patients with BPH. Chin is an associate professor at the University of Wollongong, New South Wales, Australia.
The Zenflow is essentially a spring system. It's made of nitinol, and it's designed to open up the prostate, or the prostatic urethra, to allow relief of obstruction secondary to BPH.
Most other treatments associated with BPH management involve either ablating the prostatic tissue, resecting it, causing some kind of thermal damage, or pulling it aside, which requires you to pierce the prostate and pull the adenoma to one side. So, the main advantage with regard to the Zenflow is that there's no piercing, there's no trauma, and there's no heat involved with the treatment. And what it does is essentially open the prostate and allow relief of that obstruction. It can be done under local anesthetic, and it's done through a flexible cystoscope. It's not a rigid cystoscope, so it should be a bit more comfortable for patients during the implantation.
I wasn't sure what to expect with regard to this. I was involved with the initial trials and the feasibility studies with other devices as well, so this seemed to me similar to a stent or a Memokath, but there's a lot less metal involved with it. One of the things that we did find was that the durability was pretty good. Up to 3 years, there was still good relief of symptoms. It seemed to last a good amount of time. It's hard to know when you go into a completely new device as to what to actually expect because you always think, "Is the prostate going to grow? Is it going to be durable? Can you actually remove it?" With this particular device, it seems that so far, it's durable out to 3 years, and in the cases that have been removed, they seem to be able to be removed quite easily. It also doesn't stop you from doing something else if it fails, or if it doesn't work.
The take-home message is that this minimally invasive surgery for BPH is rapidly expanding. There are lots of different devices that are being developed and I think there's been a new focus on trying to treat men with minimally invasive surgery. The Zenflow device is certainly something that appears to be able to be placed quite easily, seems to be minimally invasive, and so far seems to be durable. But really, the pivotal trials are what's going to determine if this is going to be useful in the long term. The initial results seem to be promising. But like with everything else, the trials are really what's going to tell us whether this is going to be a keeper in the end.
The Zenflow company is looking to initiate a pivotal trial. It's called the BREEZE trial to pave the way for FDA clearance. It's going to be a randomized control trial, as most minimally invasive medical devices go through. And that'll probably be the trial that will determine if this is going to be useful in the long run.
It's exciting to be part of any development of a new device. And I think that it's certainly a device to keep your eye on and, like I said, we can only go and test it in a trial basis to know definitely whether it's going to work. But so far, the initial results seem to be promising.
1. Chin P, Salvador L, Guerra G, et al. Evolution of the Zenflow Spring System: A novel nitinol implant for benign prostatic hyperplasia (BPH). Paper presented at: 2021 American Urological Association Annual Meeting; September 10-13, 2021; virtual. Abstract MP09-03