Initial Commercialization Phase Begins for Plus Medica's Blueflow Venous Stent in Europe

April 3, 2018—Plus Medica, a Germany-based medical device company, announced that the first 10 patients have been treated with the company’s Blueflow venous stent, which is primarily used as an extension stent in patients with postthrombotic syndrome (PTS) and lesions that extend below the inguinal ligament. The device received European CE Mark approval in January 2018. In this initial postapproval commercialization phase, the device will be made available to experienced, dedicated venous centers. In Germany, the device is being distributed under an agreement with AB Medica.

According to the company, the Blueflow device is a nitinol, hand-woven, two-wire braided stent designed to be highly flexible for the treatment of venous outflow obstructions of the lower extremities. It is available in diameters of 12 to 18 mm and lengths of 60 to 150 mm.

The first cases were performed by Michael Lichtenberg, MD, at Klinikum Arnsberg in Arnsberg, Germany, and Nils Kucher, MD, at University Hospital Zurich in Zurich, Switzerland.

In the company's announcement, Dr. Lichtenberg reported that the venous stent showed very good results in all patients. He stated, “We were pleasantly surprised with the performance of the device. We could implant the stent perfectly in the common femoral vein and the external iliac vein. Proximally, we implanted other dedicated venous stents and then used Blueflow as an extension, and with this combination, we have achieved very strong clinical outcomes so far.”

Prof. Kucher implanted the Blueflow device in four patients with PTS from various causes, and all patients experienced relief from symptoms such as pain and swelling after stent implantation. He said that the characteristics of Blueflow make the stent an ideal solution for the inguinal ligament area and commented, “Until now, we did not have a stent for this indication. Laser-cut stents often present problems in the ligament area as they are a bit too stiff and tend not to move with the vessel. As Blueflow is a woven stent, it does move with the vein. At least theoretically, the risk of fracture should be quite low, and in fatigue tests, we did not see any fractures with the device.”

Prof. Kucher also noted that in addition to its high flexibility, the device can also provide resistance in areas where more radial force is needed. He commented, “The stent is so flexible that you can wrap it around your finger without compromising the lumen. In PTS, you do not need much resistance in the groin, but in cases where there is a need for resistance, you can compress the stent and get more radial force.”