heart

Treatment of Atrial Septal Defects remains newsworthy and competitive as the main players vie for the upper hand. Now, a week before TCT 2012, Gore announces the first patient in its U.S study to have received its new septal occluder.

UK regulatory agency the MHRA has issued a device alert relating to the MicroPace 4580 from Pace Medical, distributed in the UK by APC Cardiovascular. Full details of the alert and required actions can be found here.

SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart, announced today that revenue and implants for the first nine months of 2012 have exceeded the company’s best 12-month totals to date.
PR Newswire (http://s.tt/1pMln)

It’s not often we get to cover a story from Slovenia, so here’s one with the news that SynCardia Systems, Inc.has announced that a Slovenian patient fitted with its temporary Total Artificial Heart, has now received a donor heart after 256 days of life with the device.

Cardiac Science Corporation, a global leader in external defibrillation, diagnostic devices and monitoring systems, has unveiled the Burdick® 4250 Holter recorder—a wearable heart monitor half the size and weight of its Holter recorder predecessor.

Medtronic, Inc. has announced CE Mark for its new Affinity Fusion® oxygenation system, opening the door to a European launch. The system, which oxygenates and removing carbon dioxide from blood during various open-heart surgical procedures, incorporates numerous innovations for claimed patient safety and ease of use.

Congenital heart surgeon James Hammel, M.D., on Thursday presented a video demonstration of a novel infant cardiac surgical technique at the joint meeting of the Congenital Heart Surgeons’ Society and the European Congenital Heart Surgeons Association in Chicago. The technique allows many complex heart defect repairs, including the Norwood operation for hypoplastic left heart syndrome, to be performed more quickly and safely.

A new study published in the current issue of the New England Journal of Medicine (NEJM), concludes that survival using the Berlin Heart’s EXCOR® Pediatric Ventricular Assist Device (VAD) as a “bridging therapy” for children in need of a heart transplant is “significantly greater” than the standard-of-care ExtraCorporeal Membrane Oxygenation (ECMO).

Canadian company CellAegis Devices, Inc., has announced that it has received a CE Mark for its autoRIC™ Device, which the company says for the first time allows simple, consistent, reliable and cost-effective automation of remote ischemic conditioning at the point of care.

Terumo Cardiovascular Systems has issued guidance regarding what to do in the event of a false air bubble detector alarm, together with some corrections to the user manual, but is not recalling the devices, nor suggesting withdrawal from use.

A few days ago we covered the story of Claret Medical’s first-in-human study using its original CE Pro embolic capture device. At the time we felt there were a few unanswered questions, so went back to Claret for some more information. This after all is a very promising looking device with genuine patient welfare consequences.

Direct injection of stem cells and other biotherapeutics into the myocardium is quite a hot topic, so the announcement of an optimised injection catheter must be well timed.

St.Jude Medical’s Bi-Annual Product Performance Report highlights positive results for its Optim coated leads, while also accepting an ongoing problem with older Riata products.

The wonders of effective PR. Either that or RhinoChill® is taking off all on its own merits as this innovative portable brain cooling system receives coverage in all the right places. The concept of brain cooling for heart attack patients, taken right to the front line.

Another fascinating study shows a positive effect of stem cell infusion in post-infarct patients when compared with standard of care control group.

Turmeric is supposed to be good for us, but now its beginning to look like a wonder spice as researchers suggest it can reduce post cardiac surgical incidence of heart attack in a placebo study.