Cardio

Occlusion of the Left Atrial Appendage has become a recognised preventative measure in the AF patient, this anatomical feature being the source of the majority of clots. Now occlusion has been made easier with the CE marking and introduction of a next generation device from St.Jude Medical, Inc.

The first patient has been treated in the Boston Scientific’s ZERO AF clinical trial to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Temperature Ablation Catheter in patients with symptomatic, drug refractory paroxysmal atrial fibrillation. This international, multi-center study will include up to 472 patients at 33 sites in the United States, Europe and Asia-Pacific.

Covidien has announced the commercial launch of the OneShot™ Renal Denervation System, an over the wire balloon-based irrigated catheter technology for the treatment of high blood pressure or hypertension.

Cardiac device and remote monitoring company Biotronik, has gained U.S. FDA approval to commence its ProMRI® clinical trial under an Investigational Device Exemption (IDE). Recruitment is underway.

Phoenix Cardiac Devices, Inc., a medical device company with a novel method of repairing leaky heart valves without open-heart surgery, has enrolled its first patient in a clinical trial aimed at achieving CE Mark approval in Europe.

It’s a boardroom thriller of a story, a David and Goliath tale of intrigue and no little desperation. Quite what the board of AorTech or for that matter St.Jude have gone through over the past year, goodness knows, but it looks like the turbulent waters have stilled at last.

St.Jude’s shareholders are a resilient lot. It’s been bad stuff on top of bad stuff for ages, but now that Durata seems to be weathering the storm and the coating supply deal is secured, there’s just the simple matter of dealing with a stern warning letter from the FDA over its practices.

When a company enters into a study as big as this one, it must be pretty confident of a favourable outcome. In the case of Medtronic’s New CRT-P study the company will win big if it can show patient benefit from treating earlier stage heart failure.

St. Jude Medical, Inc. revenues for the quarter just ended again showed a decline compared with the equivalent period a year ago, although the drop-off was overall slightly less marked than it had been in Q3. And the bottom line held up as cost saving measures played out.

Abbott’s newly announced Absorb™ absorbable stent trial is unquestionably huge, the number probably driven by the quest for significant results and the additional study end points identified in the protocol. Data from the ABSORB III trial will support U.S. regulatory filings for the device.

Stentys is trumpeting results from its APPOSITION II clinical trial, published in the December issue of JACC Cardiovascular Interventions, which suggest their device completely prevents gapping between stent and vessel wall.

Heart assist device company Thoratec Corporation has announced that the U.S. FDA has granted an Investigational Device Exemption (IDE) to commence the REVIVE-IT study utilising the HeartMate II® Left Ventricular Assist System.

A new company, CardioLogical Solutions, has been formed from the merger of Emboline and VasoStitch, to provide a comprehensive suite of technologies. The focus will be on addressing the three biggest and most pressing clinical needs to make TAVR procedures truly percutaneous and safer.

Mitral valve repair specialist company NeoChord, has received CE-marking for its technology that allows the implantation of artificial chordae tendinae, a proven technique for the repair of mitral valve prolapse, via a transapical, off-pump procedure.

Abbott’s XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has received U.S. FDA approval and is to be launched immediately in the United States.

Pioneer Surgical Technology, Inc., a leader in innovative medical devices, has created an office in Konstanz, Germany, demonstrating its commitment to grow in what it calls a key market.