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.

The U.S. Food and Drug Administration has approved PMA supplement for Endologix, Inc.’s Powerlink XL® System that includes novel suprarenal stent grafts along with the Powerlink XL stent graft. The system used in the minimally invasive procedures to treat abdominal aortic aneurysms (AAA), now, has broadened indication. Endologix provides a choice to physicians for the optimal device for the treatment of various patient anatomies. This marks the entry of Endologix in a new market segment as 15% of endovascular AAA applications are for patients having aortic necks greater than 26 millimeters.

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 (FDA) has given an unconditional Investigational Device Exemption to Berlin Heart Inc.’s EXCOR(R) Pediatric ventricular assist device (VAD).The device is a cardiac support system that is useful for pediatric patients who are critically ill and have been suffering from a severe heart failure. The system is a great support for patients waiting for a heart donor for transplantation.

St. Jude Medical, Inc. has received CE Marking for its implantable cardiac monitor (ICM), SJM Confirm™. The most compact ICM in the market (equal to the size of a thumb drive) is designed for the detection of atrial fibrillation and other abnormalities in heart rhythms. The device is implanted subcutaneously, just under the skin near the upper part of the chest. It can also be implanted, under local anesthesia, in an outpatient application. The system’s sensing algorithm helps in detecting small, wide-ranging signals in a better way.

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 granted clearance to Physio-Control, Inc. for the commercialization of LIFEPAK 20e defibrillator/monitor in the United States. The device is an enhancement of the LIFEPAK 20. The new features include a stronger (Lithium-ion) battery and an on-screen fuel gauge. The novel version, also, is designed to facilitate easy transportation. This will help the hospitals to meet the standards set by Joint Commission for Accreditation of Healthcare Organizations to ensure the availability of resuscitation services in all the areas.

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.

The U.S. Food and Drug Administration has approved the commercialization of Boston Scientific Corporation’s TAXUS® Express2™ Atom™ Paclitaxel-Eluting Coronary Stent System. Designed for the treatment of small coronary vessels, the system is the first drug-eluting stent (DES) which has got the FDA approval for sale in the American market for use in vessels smaller than 2.25 mm in diameter.