Cardio

On-X® Life Technologies Inc. has announced that it will officially launch its On-X Plus 1.5 Aortic Heart Valve at the Annual Meeting & Cardiothoracic Forum of the Society for Cardiothoracic Surgery in Great Britain & Ireland, March 10-12, Edinburgh, Scotland.

Long term clinical outcomes, presented at last month’s Cardiovascular Research Technologies Conference suggest that Micell has found an optimal combination of rapid absorbable polymer, coupled with anti-restenotic drug, yielding impressive results at 18 months.

Heart assist device company Thoratec Corporation has initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller. The advisory follows four deaths among patients while initiating switches of controller.

Frequent visitor to our pages, cardiovascular device company Biotronik has announced the first implantations of the Sentus ProMRI® lead.

Reuters has reported the death of the first patient fitted with an artificial heart made by the French company Carmat following implantation of the device in December. Sad as the news is, the device has actually achieved its primary efficacy outcome by surviving over a month post-transplant.

Atrial Fibrillation device specialist AtriCure, Inc. has announced fourth quarter and full year 2013 financial results showing 16 percent revenue growth for the year. It also looks like the Estech acquisition is working out nicely.

Cardica, Inc. is a relative minnow in the world of minimally invasive surgical stapling devices. Now however it has announced two significant new FDA clearances that may well help it to compete with its rather bigger adversaries.

Patient enrollment has been initiated in Japan in the pivotal clinical trial of the COMBO Dual Therapy Stent™ (COMBO Stent) from Hong Kong based cardiovascular device specialist OrbusNeich.

Paragonix Inc has big ideas about extending transit and storage time for donor hearts. For now though it’s satisfied with a new FDA clearance that sees its Sherpa Pak system good to enter the market for use within current guidelines.

Contact force-sensing has become something of a buzz word in cardiac ablation as the benefits of being able to avoid too much or too little contact become apparent. Now Biosense Webster has become the first to get its contact force sensing catheter FDA approved.

Cardio/Vascular device specialist Volcano Corporation has joined the list of companies issuing their fourth quarter and full year results for 2013. Quarterly revenue was up 6 percent on a constant currency basis, but losses increased dramatically as the company accounted for significant restructuring charges in the period.

It’s been pretty quite in Renal Denervation territory since the January bombshell of Symplicity HTN-3 clinical outcomes. Nonetheless, one company, Cordis, has pushed ahead with its CE marking and now been granted its EU approval.

Medtronic is launching its tiny Reveal LINQ heart monitor globally following U.S. FDA and Euroepan CE mark clearance. The Reveal LINQ Insertable Cardiac Monitor (ICM) System is a five times smaller than the previous smallest implantable cardiac monitoring device

Direct Flow Medical is a relative minnow in Transcatheter Valve World, but a new cash injection totalling $50million will help it expand and progress its plans to gain U.S. FDA approval as soon as it possibly can.

Some solid revenue growth for Medtronic, compared with the same quarter a year ago, were somewhat spoiled by a $200 million write down following the poor outcome from its much vaunted Symplicity HTN-3 Study.

Atrial Fibrillation raises stroke risk five-fold. But it’s often asymptomatic and paroxysmal, leaving patients with a risk they either know nothing about or that medial professionals can’t detect. Medtronic’s monitoring solution has now been found to outperform the current standard of care, raising the possibility of reducing incidence of cryptogenic stroke.