Biotronik, a global biomedical device manufacturer based in Berlin, Germany, recently received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for its Pulsar-18 self-expanding stent. The Pulsar-18 is another entry in Biotronik’s product line of peripheral artery stents.

The IDE approval by the FDA gives the company the ability to sign up patients for a U.S.-based clinical trial. These patients will become part of a larger clinical trial currently underway in Canada and Europe.

The new Pulsar-18 self-expanding stent provides support for the superficial femoral artery. The stent is available in a variety of lengths for the treatment of different-sized lesions. The new stent is compatible with the standardized 4F sheath system. The 4F sheath system provides a wide range of stent diameters from four to seven millimeters. In addition, the 4F sheath system provides stent lengths of 20 to 200 millimeters.

Dr. Carlos Mena is a surgeon at the Yale University Medical Center. He performed the first Pulsar-18 surgical implantation. In prepared remarks, he said, "Performing an entire procedure through a 4F sheath can reduce the risk of patient bleeding and allow them to ambulate more quickly." He continued, "I'm excited to be able to provide these benefits to my patients using an entirely 4F system of tools."

References

http://www.biotronik.com/files/B7BA5BAD2B64C2D7C1257AB6003BF7CF/$FILE/BIOTRONIK_PR_BIOFLEX_1st_Implants_EN.pdf