CircuLite, Inc. has announced that it has received ISO 13485 certificate of registration from BSI Group for the Company’s Quality Management System in Saddle Brook and Aachen for the design, manufacture and distribution of the Synergy™ Pocket Micro-pump for the treatment of chronic heart failure. ISO 13485 is a regulatory certification for the international medical industry, created by the International Organization for Standardization (ISO), which defines standards for the design, development, production and distribution of medical devices, and also ensures conformity with certain quality controls in the development of safe and effective devices.

Medtronic has announced the U.S. launch of the Talent Abdominal Stent Graft on the Xcelerant Hydro Delivery System. EVAR is a treatment for aortic aneurysm, a bulge or weakening in the body’s main artery that can rupture with fatal consequences if left untreated. EVAR involves the navigation of a stent graft, via the body’s arteries, to the aorta. The stent graft is then deployed to create a tube within the aorta, reducing pressure on the aneurysm and the risk of rupture. EVAR is a minimally-invasive alternative to open surgical repair.

Medtronic, Inc. has announced the U.S. market launch of the Sprinter Legend (semicompliant) and the NC Sprinter (noncompliant) balloon dilatation catheters on a rapid exchange delivery system. Recently approved by the U.S. Food and Drug Administration, the Sprinter Legend balloon catheter provides the latest innovations in balloon technology and is equipped to address difficult lesions in coronary angioplasty procedures. The Sprinter Legend balloon catheter features the lowest pre-dilatation profiles, making it suitable for use in challenging lesions, as well as allowing for the use of two balloons simultaneously in a small, guide catheter.

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.