Cardio

Last month St. Jude Medical, Inc. told us it had gained CE mark approval for its next-generation Ellipse™ and SJM … continue reading “FDA Approval For St. Jude’s Ellipse™ and Assura™ ICD/CRT-Ds”

Abbott is commencing a trial to study its innovative “Dissolving” Heart stent compared to its own drug-eluting stents in patients with Coronary Artery Disease.

Cardiac arrhythmia specialist company, Cardiac Insight, Inc., has received US FDA 510(k) clearance for its Stealth™ body-worn ECG monitor

St. Jude Medical, Inc. has gained U.S. FDA approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.

Heart device and monitoring company Biotronik, has completed enrollment for its the highly anticipated IMPACT study. The study aims to investigate whether the use of Biotronik Home Monitoring® in conjunction with anticoagulation can reduce the risks of stroke, systemic embolism and major bleeding in cardiac device patients

Market intelligence company Millennium Research Group (MRG), reckons the 2013 Japanese launch of transcatheter aortic valve implants, will spur accelerating growth in the market. Earthquakes, the tsunami and economic factors might hold things back a bit though.

Seemingly hardly off our pages in recent weeks, Biosensors International Group, Ltd., cardio device company has entered into a licensing … continue reading “Biosensors Steps Into Drug Eluting Balloon Markets With Eurocor OEM Deal”

We’re still clearing up after EuroPCR with a few news items worthy of comment in this week’s editorial.

Such are the wonders of the US financial disclosure rules, Edwards Lifesciences Corporation is compelled to tell us it has received a warning letter from the U.S. FDA resulting from an inspection of Edwards’ facility in Draper, Utah.

When Justin Ryder, 35, was discharged from University of Arizona Medical Center in Tucson on May 20, he had a new donor heart beating in his chest and a new baby boy waiting for him at home in Las Vegas, his heart transplant made possible by 83 days of life with the SynCardia temporary Total Artificial Heart.

The acquisition of Spectrum Dynamics by Biosensors International Group, Ltd., is complete. Biosensors has acquired substantially all assets of Spectrum Dynamics, a leader in advanced functional assessment technologies, including those used to evaluate patients for cardiac interventions.

OrbusNeich has launched what it is hoping will be a new genre of coronary stent. The company’s COMBO Dual Therapy … continue reading “Cardiologists Can Have Cake And Eat It With OrbusNeich’s Dual Therapy Stent”

Another one of the renal denervation big boys sees data presented which confirms sustainable blood pressure reduction. This time its Boston Scientific, seeing clinical results using its recently acquired Vessix balloon-based system.

The Helio System (TF-FA) is a new investigational device, being developed for use with the Sapien XT Transcatheter Heart Valve. Results from a small, first-in-human feasibility study of its successful use in high-risk aortic insufficiency were reported at EuroPCR 2013.

EuroPCR has been the main focus of medlatest’s editorial this week. We’ve spotted a growing trend for companies to use vehicles like ours to get their news across. Never has that been more evident than this week, which has seen an unprecedented number of winning tales.

InspireMD 6-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrate that the MGuard Embolic Protection Stent (EPS) outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.