Straub's S-Series Catheters Receive Upgraded CE Mark Approval

April 28, 2011—Straub Medical AG (Wangs, Switzerland) announced that it has received an upgraded CE Mark approval for its Rotarex S and Aspirex S families of rotational endovascular catheters that are designed to restore blood flow in occluded vessels. The S-series represents the latest generation of Rotarex and Aspirex catheters. The Rotarex S and Aspirex S were launched in mid-2010 with a class-II CE Mark, which allowed for the treatment of occlusions of peripheral arteries.

According to the company, with the regulatory upgrade to class-III products, 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 (including abdominal vessels). Both catheters are indicated for use in native blood vessels or vessels fitted with stents, stent grafts, or native or artificial bypasses.

The Aspirex S catheters are intended to be used for the removal of fresh thrombotic or thromboembolic material. Additionally, the new indication for Aspirex S catheters includes venous use. The Rotarex S catheters are intended for removal of thrombotic, thromboembolic, and atherothrombotic material from fresh, subacute, and chronic occlusions.

Straub Medical stated that the devices feature a rotating helix inside of the catheters that concomitantly aspirates and fragments the detached material and transports it through the inner lumen of the catheter into a collecting bag outside of the patient's body. The catheters allow for reopening of up to 1 cm of occluded vessel per second, depending on the consistency of the occlusion material. Blood flow is immediately restored. After successful treatment of the lesion, the rotation is stopped and the catheter is withdrawn from the blood vessel.