Cardio

In short We don’t know whether the FDA has its pen hovering over the tick box for MitraClip or not, … continue reading “Abbott’s MitraClip Suffers Untimely Setback”

Angiotech Pharmaceuticals, Inc. has entered into a definitive agreement to sell certain of its subsidiaries, comprising Angiotech’s Interventional Products Business, to Argon Medical Devices, Inc., for $362.5 million in cash consideration. Angiotech expects the transaction will close prior to the end of April 2013.

Sorin’s newly approved RESPOND CRT trial aims to demonstrate clinical benefit of innovative SonR® CRT optimization system in cardiac resynchronization therapy.

FDA proposals could see Automated External Defibrillators raised to class III status in an attempt to help manufacturers reduce the rather high incidence of adverse events that have been catalogued over recent years.

Back on the quest for regulatory nirvana, this week’s editorial looks at two events which arguably characterise the state of … continue reading “Medlatest’s Weekly “View From The Med” Online Now”

Eight-year study confirms PFO closure was superior to medical therapy alone in reducing risk of recurrent stroke in prespecified per-protocol and as-treated cohorts.

In short What a peculiar and unusual series of events the final throes of MitraClip’s progress to FDA approval have … continue reading “FDA Panel Not Unanimous On MitraClip, But Approval Likely”

The Left Atrial Appendage is a troublesome little design feature. It doesn’t appear to possess any purpose and can be the source of clots, especially in AF patients, leading to an attendant stroke risk. So let’s block it off? Eu regulators seem happy with that idea, U.S. less so, which again shows up our differences.

Newly published data indicates St. Jude Medical Trifecta Heart Valve closely resembles the hemodynamic performance of a natural, healthy heart valve

FDA’s reading material, issued in advance of today’s PMA review meeting are not recommending the approval of the MitraClip implantable heart device, citing a lack of “valid scientific evidence” of safety and effectiveness. And a lack of comparator group.

Thoratec has successfully completed the first human use of HeartMate PHP (Percutaneous Heart Pump). The first PHP patient was supported for over 60 minutes during a high-risk percutaneous coronary intervention.

Volcano Corp’s new device, called Valet is a high performance microcatheter that is used for guidewire support, wire exchange and contrast injections during complex coronary and peripheral interventional procedures and is particularly useful for highly stenosed lesions.

Transcatheter heart valve company Direct Flow Medical®, Inc., has been trumpeting the DISCOVER Trial results presented Sunday at the American College of Cardiology (ACC) Annual Meeting. Patients treated with the Direct Flow Medical® Transcatheter Aortic Valve System achieved excellent survivability and sustained hemodynamic improvements with minimal occurrence of aortic regurgitation at six months.

In short A new report, another on the subject of renal denervation(RDN), claims the world market for these devices is … continue reading “New Report Looks Into Global RDN Devices Crystal Ball”

Two interesting clinical trials were reported at ACC Scientific Sessions last weekend. Firstly Edwards Lifesciences’ Sapien XT seemed to offer improvements in rate of vascular events compared with its big brother. Also, in the pivotal PARTNER study of Sapien, results were comparable with conventional surgery despite ongoing high comparative incidence of paravalvular leakage.

In short Last December we announced that Texas-based medical device manufacturer BiO2 Medical, Inc., had gained CE Mark approval for its … continue reading “Triple Lumen Catheter Hits The Streets In UK”