The FDA has approved Medronic’s Integrity Coronary Stent System, based on an advanced biomedical engineering called continuous sinusoid technology, enabling the exploration of other new device concepts, such as a polymer-free drug-filled stent. The stent is said to feature a new, more flexible construction which is easier for surgeons to insert. A stent is a metal mesh which is placed inside an artery after it has been cleared of blockage.

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CorMatrix Cardiovascular, Inc. announced that FDA has granted conditional approval for the start of a multi-center, randomized clinical trial to demonstrate the safety of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation. Patients enrolled in the trial will undergo circumferential reconstruction of the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures and will be compared to subjects who do not undergo pericardial closure.

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A regional quality improvement effort aimed at increasing the use of preoperative beta-blocker (BB) usage to help prevent postoperative myocardial infarction (POMI) was revealed at the 64th Vascular Annual Meeting® presented by the Society for Vascular Surgery®. This quality improvement effort was implemented at 11 centers participating in participating in the Vascular Study Group of New England (VSGNE) from 2003 through 2008.

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“Nanoburrs” are nanoparticles coated with a sticky protein that makes them cling onto artery walls while they slowly release drugs: the US researchers who are developing them hope they will one day provide an alternative to drug-releasing stents in fighting heart disease. The Massachusetts Institute of Technology, (MIT) and Harvard Medical School researchers, wrote about how they developed and tested the nanoburrs as potential drug-releasing agents for targeting and repairing damaged blood vessels.

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The FDA has cleared the way for St Jude Medical Inc to launch its new EnSite velocity Cardiac Mapping System. The new system has been designed to help doctors diagnose and guide therapy to treat abnormal heart rhythms. The system, used in minimally invasive electrophysiology procedures, uses catheters with electrodes inserted into a cardiac chamber. The electrodes then relay electrical information from the heart in a 3-D anatomical model.

A Dutch study showed that people who took preventive doses of the statin pills, such as Lescol, before and after their operations to get an artery unclogged or repaired were much less likely to die or have a heart attack afterward. Statins are widely prescribed to reduce cholesterol and prevent heart disease.

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.

 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.

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.

The first CryoValve SG pulmonary human heart valve, manufactured by CryoLife, has been received by the first patient. The product was approved by the FDA in February and is used in replacing the malfunctioning native pulmonary valves in patients. Children with congenital heart defects can also receive the valve for right ventricular outflow tract reconstruction procedures.