Straub Medical AG announced that it has received an upgraded CE mark approval for its Rotarex S and Aspirex S families of rotational endovascular catheters. These catheters restore blood flow in occluded blood vessels.
The technically optimised S-series, representing the latest generation of Rotarex and Aspirex catheters, have been introduced to the market in mid 2010 with a class-II CE mark approval, which allowed for the treatment of occlusions of peripheral arteries. The recent regulatory upgrade to a CE class III product comes along with a notably enhanced indication: the catheters, in combination with the Straub Medical Drive System, are now intended and marketed for the percutaneous transluminal removal of material from occlusions of blood vessels outside the cardiopulmonary, coronary and cerebral circulations. Both Rotarex S and Aspirex S catheters are indicated for native blood vessels or vessels fitted with stents, stent grafts or native or artificial bypasses.
While Aspirex S catheters are intended to be used for the removal of fresh thrombotic or thromboembolic material, Rotarex S catheters are intended for removal of thrombotic, thromboembolic and atherothrombotic material from fresh, subacute and chronic occlusions.
“The successful upgrade to a CE class III product and the approval of the enhanced indication underline the safety and effectiveness of our devices”, stated Walter Mayerl, director Regulatory Affairs at Straub Medical. “We are glad that our devices can now be used to help an even wider range of patients suffering from vascular occlusive disease”, said Immanuel Straub, founder, chairman and president of Straub Medical AG.
“An important advantage of our technology is that it allows for rapid vessel reopening and immediate restoration of blood flow without the potential risks of bleeding when administering thrombolytics, or of inducing barotraumata or embolisations when dilating the lesion with a balloon, or of vessel trauma and neointima hyperplasia when implanting a stent”, illustrated Dirk Dreyer, director Global Sales & Marketing at Straub Medical. “And even if the occlusion occurs in a previously stented region of the blood vessel or in a bypass, our catheters can be used to safely reopen these segments again.”
The enhanced indication includes the approval of venous use of the Aspirex S catheter family. “The enhanced approval together with the venous indication for Aspirex S greatly accelerate Straub Medical’s evolution as a leading provider of devices for the treatment of vascular occlusive disease,” explained Gido M Karges, Managing Director of Straub Medical AG. “Being established as one of the market leaders in the treatment of peripheral arterial occlusive disease, we now aim to widen the portfolio of both products and indications. One of our goals is to improve the physician’s ability to treat venous disease, e.g. DVT, with our new generation of catheters and a dedicated range of complementary devices designed specifically for venous use. With enhanced indications and products for arterial and venous use we hope to expand interventional treatment to patients who previously would not have had that treatment option.”