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.

The Polymer Technology Group (PTG) indicated that its customer, Sunshine Heart Inc., has passed the five-year milestone on durability-testing of its C-Pulse implantable heart assist device. C-Pulse is designed to be a non-blood-contacting heart assist therapy for treating patients with moderate to severe heart failure, a condition in which the heart progressively loses its ability to efficiently pump blood throughout the body. C-Pulse includes two polymers from PTG.

ES Vascular has announced that it has received a CE Marking approval for its Open Aortic Stapler (OAS) system. The OAS system is to be used for mechanical suturing technology of aortic synthetic grafts during open repair of AAA and other aortic reconstructions. The approval allows commercialization of the device in most European countries.

InspireMD has achieved positive results with its MGuard coronary stent in an ongoing multicenter trial aimed at establishing the safety and efficacy of the product in high-risk patients with complex lesions. The study’s six-month data demonstrates no thrombosis and an overall MACE rate of 6.6%. The data also highlight the efficacy of MGuard in maintaining blood flow through the treated vessel after six months, according to the company. The product, which combines a coronary stent with an embolic protection device, has received a CE Marking to treat patients with coronary artery diseases.

                                   Boston Scientific Corp. was given European CE Marking for its new ALTRUA family of pacemakers. ALTRUA pacemakers are used to treat bradycardia, a condition in which the heart beats too slowly. ALTRUA is flexible and features a sensor to regulate the heart after experiencing physical activity or emotional stress and an automatic capture capability designed for automatic and accurate ventricular pulse management.

Researchers have indicated that an enzyme found in coronary plaques may be responsible for significant number of cardiac patients suffering from heart attacks and stroke, despite the widespread use of cholesterol-lowering drugs. The enzyme makes plaque more vulnerable to rupture and block blood flow. According to new research, the drug darapladib, taken in adjunct to the treatment of statin drugs, may offer a way to fight that risk as it safely and effectively lowers the activity of the Lp-PLA2 enzyme.

Photo by Patrick J. Lynch

 CorMatrix Cardiovascular Inc. has received 510(k) clearance from the FDA for its CorMatrix ECM(TM) for Cardiac Tissue Repair, which utilizes the company’s proprietary ECM Technology(TM). The company’s platform ECM Technology provides a natural bioscaffold that enables a patient’s own host cells to repopulate and repair damaged tissues. The CorMatrix ECM, which is currently cleared for the reconstruction and repair of the pericardium, can now be used for suture-line reinforcing, buttressing for soft tissue reaproximation, repair of cannulation sites and bleeding sites, and as an intracardiac patch or pledget for tissue repair of structural problems such as septal defects.

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.

Abiomed Inc. has received a positive national coverage determination from the Centers for Medicare & Medicaid Services (CMS) that allows coverage of the AbioCor Total Replacement Heart. The AbioCor implantable replacement heart is designed to extend the lives of patients who would otherwise die of heart failure. AbioCor can potentially offer an improved quality of life as a patient can be mobile and a productive lifestyle.

 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.