Zenflow Spring System Shows Promising Results in Early Trials for BPH Patients
More minimally invasive treatments are being developed to manage benign prostatic hyperplasia, including the new Zenflow Spring system. This is a new experimental device implanted transurethrally into the prosthetic urethra with the unique ability to be safely removed.
In a recent study, presented at the 2021 American Urological Association annual meeting,1 Peter Chin, MD, and the co-authors evaluated the effectiveness of this new technology in the treatment of patients with BPH. Chin is Associate Professor at the University of Wollongong, New South Wales, Australia.
Please provide an overview of the Zenflow Spring System and its use in men with BPH.
The Zenflow is essentially a spring system. It is made from nitinol and is designed to open the prostate, or prostatic urethra, to provide relief from obstruction secondary to BPH.
What are the advantages of the Zenflow Spring System over other BPH treatments?
Most of the other treatments associated with the management of BPH involve either the removal of prostate tissue, its resection, causing some kind of thermal damage, or its spreading, which requires you to pierce the prostate and pull the adenoma out. on the one hand. So, the main advantage when it comes to Zenflow is that there is no piercing, there is no trauma, and there is no heat involved in the treatment. And what it does is basically open up the prostate and provide relief from that obstruction. This can be done under local anesthesia, and it is done using a flexible cystoscope. It is not a rigid cystoscope, so it should be a bit more comfortable for patients during implantation.
What are some of the notable findings from this study, and were any of them surprising to you and your co-authors?
I wasn’t sure what to expect from this. I also participated in the initial testing and feasibility studies with other devices, so it felt like a stent or a Memokath to me, but there is a lot less metal involved. One of the things we found was that the durability was pretty good. Up to 3 years there was still good symptom relief. It seemed to go on for quite a while. It’s hard to know what to expect when using a brand new device because you always think, “Is the prostate going to get bigger?” Is it going to be sustainable? Can you actually remove it? With this particular device, it seems that so far it lasts for up 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 doesn’t work.
What is the take-home message for the practicing urologist?
The take-home message is that this minimally invasive surgery for BPH is booming. There are many different devices in development and I think there has been new interest in trying to treat men with minimally invasive surgery. The Zenflow device is certainly something that looks like it can be placed fairly easily, appears to be minimally invasive, and so far appears to be durable. But really, the pivotal trials are what will determine if it’s going to be useful in the long run. The first results seem promising. But like everything else, the practice is really what is going to tell us if it’s going to be a keeper in the end.
Is further research on this topic planned? If so, what will the attention be?
Zenflow is looking to launch a pivotal trial. It’s called the BREEZE trial to pave the way for FDA clearance. It will be a randomized controlled trial, like most minimally invasive medical devices. And it will probably be the trial that will determine if this will be useful in the long run.
Is there anything else you think our audience should know about this research?
It’s exciting to be a part of any development of a new device. And I think it’s definitely a device to watch out for and like I said one can only go and test it out to definitely find out if it’s going to work. But so far the first results look promising.
1. Chin P, Salvador L, Guerra G, et al. Evolution of the Zenflow Spring system: a new nitinol implant for benign prostatic hyperplasia (BPH). Paper presented at the 2021 American Urological Association annual meeting; September 10-13, 2021; virtual. Summary MP09-03