Preliminary Findings Presented at ISET for Auryon Atherectomy System

“The Auryon atherectomy system represents a unique, proprietary, solid-state laser with a wavelength of 355 nanometers, which is different from the currently available 308 nanometer laser that has been in the market for many years,” said John Rundback, MD, from Advanced Interventional and Vascular Services in Teaneck, New Jersey, presenting at the International Symposium on Endovascular Therapy (ISET) 2021.

“What's really unique about this is not just the wavelength, but it has a very, very short pulse duration of 10 nanoseconds, which results in a very precise, controllable, and reproducible laser energy delivery to the vessel wall, as we'll see in some of the early results. This particular wave length has a very high affinity for atheroma versus the endothelium of the vessel,” he added.

The system comes with 4 purpose-built catheters designed to treat both above- and below-the-knee segments, including the ankle. All catheters work over a standard .014-inch guidewire.

Pathfinder I Registry

Rundback presented, for the first time, some early findings from the Pathfinder I Registry, a pilot study to evaluate the safety and efficacy of the Auryon atherectomy system (AngioDynamics) under real-world conditions.

Pathfinder registry builds upon the prior IDE and CE experience, which involves a total of 147 patients with 163 lesions. In that prior experience, there were distal embolic events seen and only 8 embolic protection devices were used at operator discretion, reported Rundback. There were 16 minor dissections and zero perforations.

Mid-term patency was 87% at 6 months, with a clinically driven target lesion revascularization (CD-TLR) of 2.1% at 6 months and 4.3% (in 46 evaluable patients) at 12 months.

“The Pathfinder registry was designed to be an all-comer, real world, multicenter experience,” reported Rundback. He presented findings on 104 patients with de novo, restenotic, or in-stent restenosis (ISR) lesions in infrainguinal arteries.

Participants were a mean age of 68.4 years, 62.4% male, and with a mean BMI of 28.8. The majority had Rutherford class 2.3 lesions (52.5%), with most of the rest being Rutherford 4/5. Mean lesion length was 12.9 centimeters and moderate or severe calcification was seen in 54.8%. “Forty-four percent were CTOs and 40% were tibial,” reported Rundback.

Adjunctive therapies were plain old balloon angioplasty (POBA) in 80% and drug-coated balloon (DCB) in 20%.

“Across the board, the stenosis reduction or the luminal gain was between 24 and 31%, and this is the sort of laser cut phenomenon that I think is unique to this laser,” said Rundback.

“It doesn't matter what vessel caliber with the appropriate size laser, or what the plaque morphology is, this is a very precise, deliverable and controllable and reproducible result,” said Rundback.

He showed an example of a case where with one pass of the device (and stenting at the discretion of the operator), the patient was left with 0% residual stenosis and a lased area minimal luminal gain of 5.05 mm.

Regarding safety, 98.9% of patients had no major adverse events. There was one amputation (1.1%) at 180 days in a patient who had Rutherford category 5 and gangrene at baseline.

The bailout stent rate was 3.5% and one dissection was noted.

>At 6 months, CD-TLR was 11.1%. There were two CD-TLRs: one was at day 175, atherectomy and stenting to severely ischemic left leg due to occluded superficial femoral artery (SFA) stent. Two weeks earlier, it had been reported that the subject had not been taking anticoagulant or antiplatelet medications. The other CD-TLR was a thrombectomy and stenting at day 46 to a severely ischemic left leg due to occluded SFA stent (embolization).

“In summary, I think this represents an exciting new technology…We found it a very useful tool across a wide range of plaque morphologies and vessel beds. Future iterations on this platform will hopefully improve its performance further,” Dr. Rundback concluded.