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.

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.

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 (FDA) has granted 510(k) clearance to Cardica, Inc. to market its PAS-Port(R) Proximal Anastomosis System for use in cardiac bypass surgery. The system creates a safe connection (anastomosis) between a vein graft and the aorta (the main artery in the human body) during coronary artery bypass grafting (CABG) procedures. The current method requires that the aorta be clamped which leads to the release of tiny blood clots or particles from it. These can reach the brain and cause stroke and other neurological complications.