Cook Medical has received the CE Mark approval for its MiraFlex™ High Flow Microcatheter. Designed to complement the company’s existing embolisation products and coils, the device represents the newest improvement in micro-catheter technology. It enhances traceability necessary to access the most distal vasculature. Having an inner diameter of .025 inch, the catheter is approved for use in small vessels. It enables coil delivery in the finest way.

The U.S. Food and Drug Administration has approved Endologix, Inc.’s IntuiTrak™ Delivery System. The novel system will facilitate minimally invasive delivery. It will help  deploy the Powerlink stent graft [indicated for endovascular repair of AAA abdominal aortic aneurysms (AAA)]. The device has improved flexibility. It features advanced hemostasis control. An integrated sheath introduces ancillary devices during AAA procedure, reducing blood loss and the procedure time.

Cook Medical has launched its  Advance® 18LP Balloon Dilatation Catheter in North America. Designed to provide improved deliverability to doctors, Advance 18LP has small sheath compatibility and a low crossing profile. The .018″ wireguide PTA balloon can be used in patients having lesions of the peripheral arteries as well as obstructive lesions of native or synthetic arterio-venous dialysis fistulae. It uses advanced thermal setting of the balloon folds for better rewrap and sheath pull-back. Lower deflation time is its another benefit.

The U.S. Food and Drug Administration has cleared Lumen Biomedical, Inc.’s LBI Embolectomy System to remove fresh, soft embolus and thrombus from vessels in the peripheral vasculature. The device consists of a 0.014″ guide wire that consists of a 3D fiber-based element used along with the Xtract Aspiration Catheter that had been cleared previously. It is based on the same technology that drives Lumen’s embolic protection system. The system will be helpful in the treatment of Peripheral Arterial Disease.

The U.S. Food and Drug Administration has given the 510(k) clearance Interrad Medical, Inc.’s SecurAcath(TM) PICC with Subcutaneous Securement System. The novel method for catheter securement uses a small anchor which is deployed in the subcutaneous tissue just under the skin to hold an indwelling catheter firmly in place. The catheters, currently in use, are secured on the surface of the skin of the patient using adhesive devices. The SecurAcath system also reduces the time for catheter maintenance, bringing down the costs related to it. The risk of infection related to catheter is also lowered by improved cleaning of exit site and minimizing the motion.

OrbusNeich’s Sapphire(TM) 1.25mm PTCA dilatation catheter has received the CE Mark approval, a company announcement says. The product is slated for immediate roll-out. It affords greater pushability and superior kink resistance to the physicians. According to Professor Tan Huay Cheem of the University Hospital in Singapore, the product may be considered to be a first choice for the treatment of highly stenotic lesions.

InfraReDx has received FDA clearance for its InfraReDx LipiScan catheter imaging system used to see inside a blood vessel to assess the fat content of plaque that builds up on coronary artery walls. The device uses infrared imaging to determine how much fat and other substances are in the plaque on arterial walls by measuring light reflected back from the walls of an artery into which a catheter with a fiber-optic laser was inserted. The device is cleared for physicians who evaluate patients with coronary heart disease symptoms during a heart test known as cardiac angiography.

 Medtronic Inc. has received CE marking approval for the Defender embolic protection filter to be used during minimally invasive procedures in carotid arteries and saphenous vein grafts. The filter acts as a basket during the stenting procedure, allowing sufficient blood flow while trapping embolic debris. Without this protection, the debris can flow into other portions of blood vessels and lead to stroke.