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| Pulsar-18 self-expanding stent--Courtesy of Biotronik |
Germany's Biotronik touted a recent study of its CE-marked Pulsar-18 stent for peripheral artery disease, saying the data showed the device can be used in challenging cases of the condition.
Twelve months post-implantation, the 36 patients with lesions in their popliteal artery (located near the knee joint) had a primary patency rate of 85.4%, meaning the stent was still positioned to support the vessel wall. In addition, 87.5% of patients had not received a repeat procedure known as target lesion revascularization, Biotronik says.
All of the lesions treated were rated TASC D, the most severe classification. More than 95% of the lesions were occlusions, meaning the arterial obstructions blocked were large and long-lasting. And the average lesion length was 18.2 centimeters, Biotronik says.
"The aim of the study was to verify patency results for the Pulsar-18 stent system in routine clinical treatment of long, occlusive femoropopliteal lesions," said lead investigator Dr. Michael Lichtenberg of the Vascular Center Clinic in Arnsberg, Germany, in a statement. "Even confronting these difficult cases, Pulsar-18's 4 French system yielded strong primary patency."
The Pulsar-18 nitinol (a mixture of nickel and titanium) stent is coated with a silicon carbide layer that improves its hemocompatibility and biocompatibility, Biotronik says. The company also touts its ease of deliverability using a 4 French sheath.
"We believe that the high patency and low TLR rates, evident in all Pulsar-18 studies published so far, are the result of the stent's unique design. Pulsar-18's high flexibility and low chronic outward force appear to minimize the mechanical inflammatory response that otherwise contributes to restenosis," said Dr. Alexander Uhl, Biotronik's vice president of marketing, in a statement.
Last year, Biotronik completed enrollment in an ongoing 296-patient pivotal trial of the Pulsar-18 for FDA approval. It is already sold in more than 50 countries around the world.
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