TomTec and Medis have announced the launch of a joint cardiac imaging and analysis product for X-ray angiography and ultrasound. The combined solution is a fully integrated software package that consists of TomTec’s Image-Arena™ and Medis’ QAngio® XA quantification software. It will be available as one platform that can be integrated into the products of partnering medical device manufacturers and that connects to existing PACS, HIS, CPACS and CVIS in hospitals. The software solution drastically reduces the integration effort for industry partners and for hospitals that want to optimize their imaging and analysis processes and data management.

Medtronic, Inc. has launched the Endeavor Sprint drug eluting stent (DES) on a rapid exchange (RX) delivery system in the U.S. The Endeavor Sprint system uses Sprinter ™ balloon catheter technology. The system puts the highly deliverable Endeavor DES on an enhanced delivery platform. This makes Medtronic’s flagship DES even easier for physicians to deliver to the site of coronary blockages. The Endeavor Sprint drug eluting stent system is the latest innovation to come out of our robust product pipeline in CardioVascular.

The U. S. Food and Drug Administration has granted approval to C. R. Bard, Inc. for marketing its Flair™ Endovascular Stent Graft with an optimized delivery system. The device consists of a self-expanding Nitinol stent encapsulated within the proprietary ePTFE graft material of Bard. The product has received the indication  for use in the treatment of stenoses in synthetic arteriovenous bypass grafts. A six-month long study conducted by Bard showed that the placement of the device resulted in more than twice the primary patency of balloon angioplasty. “The Flair Endovascular Stent Graft represents the first interventional technology demonstrating superiority to balloon angioplasty in maintenance of access patency.

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.