Californian device company Nanostim, Inc., has announced the first successful implants of a leadless pacemaker in a series of 11 patients at Homolka Hospital in Prague, Czech Republic.
Cardio
Green Light For Study Means Ultimate Test For Ventricular Unloading Theory
A new study, entitled “TandemHeart to Reduce Infarct Size” (TRIS) will determine effect of ventricular unloading on myocardial salvage after acute myocardial infarction.
Public Defibrillators May Not Work
In recent years defibrillators have popped up everywhere from the shopping mall to the train station. It seems a gap in the requirement for regular testing and maintenance leaves them open to failure. A UK company has a simple test rig to address the problem.
Trial Results Suggest Biotronik Home Monitoring® Reduces Inappropriate ICD Shocks by 52%
A new paper, published in the European Heart Journal shows home-monitored patients experience 71% fewer delivered shocks and a 52% reduction in inappropriate shocks compared with a control group.
Who Owns Renal Denervation Part 2: The Plot Thickens
A therapy as potentially huge as renal denervation is bound to be tied up in claim and counterclaim, and downright confusion about who owns what. A new article tries to unpick it all.
One Year Symplicity™ HTN-2 Trial Results Show Sustained BP Reduction
Published data demonstrate the Symplicity™ renal denervation system provides blood pressure reduction in patients with treatment-resistant hypertension sustained to 12 months
First Patient In St.Jude’s ILUMIEN I Stent Guidance Study
St. Jude Medical, Inc. has announced the first patient enrollment in its ILUMIEN I clinical study, designed to show the way Optical Coherence Tomography can optimally guide stent implantation in patients with coronary artery disease.
Boston Scientific’s Ingevity™ Pacing Lead Trial Sees First Patient
A first patient has been implanted with Boston Scientific’s new INGEVITY™ pacing leads in a clinical trial designed to establish the safety, performance and effectiveness of the leads.
Miracor Proclaims Successful PICSO® System Use In UK STEMI Patient
A 38-year-old female is discharged from Manchester Royal Infirmary (Manchester, England) after successful PICSO treatment designed to improve myocardial perfusion following primary PCI
Who Owns Renal Denervation?
Renal Denervation: If you’ve not heard the phrase before, get used to it, because the therapy has so many potentially interesting applications with very promising outcomes thus far, it’ll soon be mainstream. A new article ponders the complicated intellectual property position.
Merit Medical Snare’s FDA Clearance
Merit Medical, Inc., has a new FDA 510(k) clearance to trumpet: Merit’s ONE Snare™ endovascular snare system will see its U.S. launch in January
IVC Filter/Central Venous Catheter Combo Device; EU Launch This Week
Ah, that’s a clever idea. Attach an inferior vena cava filter to a central line and you can protect patients for whom anticoagulation is not an option, against the threat of venous thromboembolism. Following CE marking BiO2’s Angel™Catheter is being launched in Europe this week.
Reclassification Means Impella Will Now Need PMA, But Can Remain On Market
The FDA has decided non roller cardiopulmonary pumps will no longer be exempt from the PMA process, meaning that devices like Abiomed’s Impella will have to undergo further steps in order to stay on the market in the long term.
First Green Light For Miracor’s Picso® Coronary Sinus Occlusion System As Study Says It’s Safe
Miracor Medical Systems GmbH has announced that the Journal of Interventional Cardiology has published the clinical results of 10 patients enrolled in its “Prepare PICSO®” non-randomised safety and feasibility study.
CE Mark For BioVentrix Revivent® Myocardial Anchoring System
BioVentrix has received CE marking for its clever Revivent™ Myocardial Anchoring System, which makes possible Less Invasive Ventricular Enhancement™ (LIVE™), a procedure that restores the left ventricle from damage done by a heart attack to what the company calls a “more optimal” volume and conical shape.
Volcano Corporation Announces Agreement To Acquire Crux Biomedical
Volcano Corporation has signed an agreement to acquire Crux Biomedical, a privately-held company that has developed a highly differentiated inferior vena cava (IVC) filter—the Crux VCF System—to treat pulmonary embolisms (PE’s).