Pedal Study Interview
Ted Gifford, MD
Hartford HealthCare
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Dr. Peter Schneider:
Hi, my name is Peter Schneider. I’m a vascular surgeon at the University of California, San Francisco. Today I’m speaking with Dr. Ted Gifford, a vascular surgeon at Hartford HealthCare in Hartford, Connecticut.
Dr. Gifford has recently authored and presented a study on pedal angioplasty using a serration balloon. This is a novel technique, so I wanted to ask him about it.
Ted, can you give us a high-level overview of your study and its key findings?
Dr. Ted Gifford:
First, Peter, thank you—it’s a great opportunity to talk about this complex problem.
We’ve noticed that when treating patients with tibial disease, it often doesn’t stop at the ankle—it extends below. In that region, we have very limited treatment options. It’s also an area where we want to avoid vessel injury at all costs.
We found serration angioplasty to be very effective for these patients. We brought together a group of investigators from both the U.S. and Germany and conducted a retrospective analysis of outcomes using serration angioplasty below the ankle.
The results we’ve seen so far have been quite favorable.
Dr. Peter Schneider:
Why is this different? Why haven’t we seen other specialty or modified balloons used in the pedal arteries?
Dr. Ted Gifford:
There are two main challenges with pedal artery intervention.
First is deliverability—you have to navigate through calcified, tortuous tibial vessels to reach below the ankle.
Second is safety. This is a high-risk area—any vessel injury during the procedure can be catastrophic and may result in major amputation.
Some of the unique features of the Serranator balloon make it well-suited for pedal intervention. The serrated strips have individual point tips that can apply up to 1,000 times greater force than plain balloon angioplasty, but at very low inflation pressures—typically 4 to 6 atmospheres.
Dr. Peter Schneider:
So the mechanism of action is different—you’re delivering higher force through focused points?
Dr. Ted Gifford:
Exactly.
With plain balloon angioplasty, pressure is applied in a non-specific way. To achieve plaque fracture and luminal gain, you often need very high pressures—up to 20 atmospheres—which can cause barotrauma, severe dissection, and vessel spasm.
With serration angioplasty, we can operate at much lower pressures—around 4 atmospheres—with nominal balloon sizes of 2.5 to 3.5 mm. The energy is delivered in a highly focused manner along the serrated strips.
Angiographically, this results in excellent outcomes with a very low likelihood of vessel injury.
Dr. Peter Schneider:
Does this mechanism give you more flexibility in choosing balloon size relative to vessel diameter?
Dr. Ted Gifford:
Yes, and that’s an important point.
One of the barriers with plain balloon angioplasty is balancing effectiveness with safety. We want to avoid being too aggressive and causing vessel injury. But using very small balloons—like 1.5 or 2.0 mm—often doesn’t achieve much below the ankle.
With serration angioplasty, we can size closer to the true vessel diameter. Using IVUS or angiography for guidance, we typically start with a 2.5 mm balloon and go up from there.
In our study, we successfully treated patients below the ankle using 3.0 mm and 3.5 mm balloons, which is quite remarkable.
Dr. Peter Schneider:
Can you talk about flow in the pedal loop and how it relates to the larger lumen you’re achieving?
Dr. Ted Gifford:
This highlights the broader challenge of treating chronic limb-threatening ischemia (CLTI).
We need to achieve not just an effective result during the procedure, but one that is durable—something that allows wounds to heal over time. Healing doesn’t happen on the table.
The luminal gain we see with serration angioplasty is both significant and appears to be durable. In this study, we observed over 90% freedom from reintervention in the pedal vessels and 97% freedom from major amputation at follow-up.
That’s quite remarkable for such a high-risk patient population.
Dr. Peter Schneider:
Before serration angioplasty, what was your typical approach for disease extending into the foot?
Dr. Ted Gifford:
My standard approach was plain balloon angioplasty. There really weren’t other good options.
Personally, I was cautious because of the high risk of vessel trauma. I didn’t want to create complications during the procedure.
However, based on both my own experience and the results from this study, I’ve become much more confident and more aggressive in treating below the ankle. We’re now seeing meaningful luminal gain and, more importantly, real clinical improvements—like wound healing.
There’s nothing more rewarding than finishing a procedure with a palpable pulse.
Dr. Peter Schneider:
Can you summarize the key clinical endpoints—wound healing, limb salvage, and other outcomes?
Dr. Ted Gifford:
Our primary endpoint was technical success—we wanted to determine if this approach was even feasible.
We defined technical success as freedom from vessel injury and less than 50% residual stenosis.
We observed:
Zero vessel injuries (no embolization, perforation, or significant dissection)
No need for bailout stenting
Only one patient with residual stenosis ≥50%
An average post-treatment stenosis of 10% across 33 patients
From a clinical standpoint:
97% freedom from major amputation at 5 months
Less than 10% reintervention in the pedal vasculature (9%)
27% overall reintervention in the treated limb (expected in this population)
89% wound healing or healing in progress at follow-up
Dr. Peter Schneider:
Now that you’ve shown feasibility and strong initial results, what’s next?
Dr. Ted Gifford:
We need to continue studying these patients. Ideally, we’ll collect more data—likely in a prospective registry format.
This is a very complex subset of patients, so randomization may not be practical. But we can continue to track both procedural and clinical outcomes.
What we’ve seen so far is very encouraging, and we’d like to validate these results in a larger population.
Dr. Peter Schneider:
How does this study influence real-world treatment algorithms?
Dr. Ted Gifford:
This study speaks directly to unmet clinical needs.
As vascular surgeons, we use all available tools—whether that’s bypass surgery or advanced endovascular therapies. But for patients with intrinsic pedal disease, options are extremely limited.
Having a tool that is both safe and effective in this space is a major advantage. Many investigators, myself included, have found ourselves using it repeatedly because of the consistent results.
Dr. Peter Schneider:
Does it make sense to start with plain balloon angioplasty and then move to serration, or go directly to serration angioplasty?
Dr. Ted Gifford:
It depends on the lesion and the approach.
As you gain experience with the technology, you start to recognize which lesions will respond well to serration angioplasty, and in those cases, I use it as primary therapy.
In more complex, multi-level disease, plain balloon angioplasty may still be used as an adjunct.
However, I view serration angioplasty as a definitive therapy, whereas plain balloon angioplasty is more of a vessel preparation step. It doesn’t consistently deliver the luminal gain we need—something we’ve clearly seen with Serranator.
