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Serration balloon catheter achieves low residual stenosis in PAD
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LAS VEGAS — Results of the PRELUDE feasibility study of a serration balloon catheter showed it greatly reduced stenosis in patients with superficial femoral or popliteal artery disease with no serious adverse events.
Researchers conducted the single-arm, prospective study of the balloon catheter (Serranator Alto, Cagent Vascular), cleared by the FDA in February, in 25 patients.
“This is a vessel-preparation catheter with four embedded serrated metal strips and a semi-compliant balloon that goes through a 6F sheath,” Marianne Brodmann, MD, interim head of the clinical division of angiology, department of internal medicine, Medical University Graz, Austria, said during a presentation at VIVA 17. “It’s designed to create linear interrupted coring along the endoluminal surface to prepare the vessel for better uptake of drugs. The serrations are responsive to the balloon’s energy, enabling controlled balloon expansion along the lines.”
All patients had stenosis > 70%, lesion length ≤ 10 cm or less and reference vessel diameters 4 mm to 6 mm. Occlusions up to 6 cm were allowed in the study. Among the cohort, 56% had moderate or severe calcification and 32% had chronic total occlusions.
The primary safety endpoint was major adverse events and perioperative death at 30 days. The primary efficacy endpoint was final diameter stenosis < 50%.
Brodmann and colleagues also aimed to confirm presence of serrations across the lesions by OCT or IVUS in an imaging subgroup of 10 patients.
Mean pretreatment stenosis was 88%. After treatment, mean stenosis was 23%, with all patients achieving stenosis < 50%, Brodmann said, noting that 4% of patients required a stent after treatment.
No patients died or had major adverse events at 30 days, according to the researchers.
The serration effect was confirmed in all 10 patients in the imaging cohort, Brodmann said.
“We were very astonished by these results,” she said. “Even severely calcified or moderately calcified patients achieved the same luminal gain as patients with no or mild calcification.”
Six-month results are expected to be known by the end of 2017, Brodmann said.
“The Serranator [Alto] is safe and effective in treating critical femoropopliteal lesions,” she said. “We had 100% technical success and the confirmation of the serration effect by OCT and IVUS. The acute results show that these patients can achieve low residual stenosis, and the device was effective in moderate and severe calcification, which surprised us. The majority of subjects were successfully treated with low pressure inflation.” – by Erik Swain
Disclosures: The study was funded by Cagent Vascular. Brodmann reports she received honoraria from Avinger, AstraZeneca, B. Braun, Bard Peripheral Vascular, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cagent, Daiichi Sankyo, Intact Vascular, Medtronic, Sanofi Aventis and VIVA Physicians.
Perspective
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Mark W. Burket, MD
The Serranator Alto is a device that holds promise. There is a lot of talk about how to get drug penetration, especially in calcified vessels. If it can be produced economically, it could be used in a calcified vessel followed by a drug-coated balloon, and could be a solution that is not cost-prohibitive but gives good long-term outcomes. That would be an encouraging step forward.
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