Cardio

Cardiovascular device specialist, Edwards Lifesciences Corporation has received CE Mark approval for its EDWARDS INTUITY Elite valve system. The company says its next-generation, rapid deployment system facilitates smaller incisions in surgical aortic valve replacement procedures

Let’s not get started on whether membership of the European Union brings good things or whether it would all be better if we had more autonomy. There’s not much room for middle ground in the debate, rather like the current Renal Denervation exchanges.

Cardiovascular device company Biotronik has announced that the first patients across the United States have received implants of the new Iforia implantable cardioverter-defibrillators (ICDs)

Cardinal Health has announced an agreement to acquire privately held extravascular closure device, AccessClosure, Inc., for $320 million, in a deal that is expected to close by early June 2014.

While Edwards Lifesciences and Medtronic slugged it out at ACC 2014 with studies comparing their TAVI (transcatheter aortic valve implantation)offerings, Boston Scientific draws our attention to new data presented at the event that says its own Lotus™ Valve System continued to demonstrate impressive performance at three months.

Presented at ACC 2014 is the first prospective, randomized study to compare transcatheter aortic valve replacement with open heart surgery in high risk patients. TAVR wins.

Italian Cardiovascular device specialist Sorin Group tells us its Perceval™ sutureless aortic valve has received CE mark approval for adult age indication allowing treatment of a wider spectrum of patients with aortic stenosis and/or steno-insufficiency.

Boston Scientific points us at a new publication that details registry data relating to the real world performance of the company’s S-ICD (Subcutaneous Implantable Cardioverter/Defibrillator) and finds the device does the job.

It’s only one study, but it’s perhaps telling that the theoretical advantages of a balloon-expandable transcatheter valve design seem to carry through into clinical reality as procedural success for Sapien XT significantly outstrips its rival CoreValve.

A combination of findings presented at ACC 2014 and a newly published clinical paper, point to a bleak future for Renal Denervation as a blood pressure reducing therapy, at least as far as Medtronic’s Symplicity System is concerned.

AccessClosure Inc., has commercially launched its Mynx Ace Vascular Closure Device at ACC 2014. The company says the device is a safe and secure vascular closure product that provides consistent results with a new, easy-to-use deployment system to seal femoral artery access sites.

Following FDA clearance in January, ACIST Medical Systems, Inc., has now announced the global introduction of the new ACIST|RXi™ Rapid Exchange FFR System – the world’s first Rapid Exchange FFR system. This device features new technology designed to provide physicians with a fast and easy way to perform Fractional Flow Reserve (FFR) procedures.

SynCardia Systems, Inc., supplier of the Total Artificial Heart, has issued a press release to tell us what other people are saying about the system, most specifically how and when to use it.

Remote monitoring of ICDs has been shown to improve patient adherence to follow-up regimes when compared with traditional repeat check-up appointments. It’s surely the biggest “no-brainer” the specialty has seen for years.

St. Jude Medical, Inc. has announced approval from the U.S. FDA for the Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which provides additional pacing innovations for physicians to treat patients with heart failure. The company also announced FDA approvals for the Assurity™ pacemaker and Endurity™ pacemaker families of devices.

St. Jude Medical, Inc. has announced the global launch of the Optisure™ Defibrillation Lead, joining the Optim™ lead family, which includes the company’s now famous Durata™ Defibrillation Lead.