January 29, 2025
Author(s):
Key Takeaways
- Signati’s Separo system achieved FDA de novo market clearance application after demonstrating safety and effectiveness in GLP data and an IDE study.
- The Separo system enables a transdermal vasectomy, allowing urologists to perform the procedure quickly and independently, freeing up clinical staff.
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“The biggest thing that I took away from using the device is that it allowed me to do the procedure by myself, without an assistant,” says Matthew J. Mutter, MD.
Signati Medical recently filed an application with the FDA for de novo market clearance of its Separo vessel sealing system for vasectomy procedures.1
The safety of the device was first demonstrated through the collection of Good Laboratory Practice (GLP) data, in which the device met the safety end points of sealing, no thermal spread, and clinically documented wound healing.2 The safety and effectiveness were further assessed in an Investigational Device Exemption (IDE) study (NCT06402773), which was first initiated in April 2024 and enrolled 8 patients.
In a recent interview with Urology Times®, Matthew J. Mutter, MD, discussed the use of the Separo sealing system for the sealed vasectomy procedure as well as the data supporting its FDA submission. Mutter is the principal investigator of the safety profile study and a general urologist in New Orleans, Louisiana.
Matthew J. Mutter, MD
Signati recently filed for FDA approval of its Separo sealing system. Could you highlight that achievement in more depth?
Let me qualify the statement by letting you know that my answer is not going to do [justice to] all of the hard work and dedication that the entire Signati team put into this. Essentially, [this] was the culmination of 4 years of hard work, working with the FDA and the entirety of the team, from fundraising to the engineering that went into the device, as well as [adhering to] the FDA regulations and compliance. Suffice it to say that this was the culmination of a long 4 years of work.
For me, it’s been very exciting to see something new and different. The advent of the no-scalpel vasectomy back in the late ’70s was such a revolutionary technique for vasectomies, [and] it really transformed the world of vasectomy. It allowed many more men to have this [procedure] with very little downtime. As such, because it’s been such a good procedure, there’s been very little innovation over these 40 years, up until Signati came to market. As urologists, we’re usually on the forefront of cutting-edge technology and surgery and all kinds of different types of procedures that we can do. I thought this fit in perfectly with urologists doing vasectomies because, again, there hasn’t been any innovation over the past 40 years. This was quite exciting to be a part of, strictly for that reason. Then, the fact that I can do this by myself, without an assistant, and it frees up my assistants to do a multitude of other clinic tasks, is also fairly revolutionary.
How is the procedure performed?
It’s a bipolar instrument, and there are sets of jaws that go around the vas deferens. This can either be done in the vasal sheath or out of the vasal sheath. The first part of the study was a safety profile. Ultimately, what Signati wants to do is a transdermal vasectomy. In other words, do the vasectomy through the skin. For this portion of the FDA safety study, this was all done outside of the skin. So, I would deliver the vas through the skin, as in a traditional no-scalpel vasectomy, and then just apply the Signati bipolar instrument to the vas deferens, in which time it seals and you’re able to remove a segment all with 1 energy delivery of the device.
The device was also explored in an IDE trial––how was that study designed? What were the key findings?
This was [completed per] request by the FDA. This was a single-arm trial, and the end point was what it would be for a vasectomy, and that’s to make a man azoospermic after the procedure. In the 8 patients [in whom] we [performed this procedure], all of them at 6 months either reached azoospermia or [had] rare, nonmodal sperm, which is perfectly acceptable within the [American Urological Association] guidelines for a successful vasectomy. So, our end point was reached.
I want to add that the safety profile was impeccable for this. No one experienced a [device-related] adverse event. As far as pain scores were recorded, there was only 1 pain score above a 0 throughout the duration of the study.
What were your initial reactions to the device?
The biggest thing that I took away from using the device is that it allowed me to do the procedure by myself, without an assistant. I don’t need my nurse in the room to help me with the procedure. Once I’m set up and I’m going, that frees up all the other staff in the office to [see] patients or do other clinic duties. That was the first thing that I thought was fantastic about it.
Another added benefit that I found is that it’s a quick procedure. So, not only am I able to do it by myself without the need of an assistant, but it was really quick. It allowed me to knock out the procedure without other issues and get the patient out the door.
References
1. Signati Medical successfully completes IDE trial for Separo Vessel Sealing System and initiates FDA market clearance process. News release. Signati Medical. December 24, 2024. Accessed January 28, 2025. https://signatimed.com/signati-medical-successfully-completes-ide-trial-for-separo-vessel-sealing-system-and-initiates-fda-market-clearance-process/
2. Signati Medical files IDE study with FDA. News release. October 3, 2023. Accessed January 28, 2025. https://signatimed.com/signati-medical-files-ide-study-with-fda/