Medtronic

With a combined revenue of $27 Billion, the acquisition of Covidien by Medtronic makes for one helluva company that promises to have fingers in every conceivable medtech pie.

Strong clinical results from Medtronic’s pivotal CoreValve High Risk study have persuaded the FDA to extend its approval to include patients at high risk for conventional surgery.

Medtronic has submitted the final module of its PMA application. A successful outcome would make the IN.PACT Admiral drug-coated balloon the first of its kind approved for Peripheral Artery Disease.

Medtronic and Edwards Lifesciences have buried the hatchet in their ongoing patent disputes with the former coughing up an immediate $750 million plus future amounts based on sales.

One of three judges has departed the room. Then his replacement votes against his view. Then someone who voted against him last time, changes her mind. Not like this is important or anything.

Medtronic, Inc. has gained CE Mark approval and will now launch its newest cardiac resynchronization therapy-pacemaker, Viva® CRT-P in Europe.

Medtronic recently gained the FDA’s nod to commence its IDE study into Evera, and the device has now seen its first implant performed, as part of the Medtronic randomized, global pivotal clinical trial that will enroll up to 275 patients at approximately 45 centers.

Two of last week’s news items have moved on a bit over the Easter weekend: Medtronic’s increasingly acrimonious spat with Edwards over the respective companies’ transcatheter heart valve offerings, and Covidien’s recall being graded Class I by the FDA.

Late last week Edwards Lifesciences announced that the U.S. District Court for the District of Delaware had granted a preliminary injunction, limiting the sale of Medtronic’s CoreValve system in the United States. The court ordered the injunction to go into effect in seven business days.

Medtronic has gained CE Mark approval for its Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System. The company says this is the first and only ICD system approved for magnetic resonance imaging (MRI) scans positioned on any region of the body.

Cardiac device company Mitralign Inc., has completed enrollment in a European study to investigate the performance of its simple, but clever system of cinched anchors in patients with functional mitral regurgitation (FMR).

Medtronic has signalled its intent to get to the sharp end in a significant market, by acquiring a majority of the shares of Biostar, which will assume the distribution of Medtronic products in Turkey. Former distributor Medicall Biomedikal A.S. will assume management responsibilities.

Presented at ACC 2014 is the first prospective, randomized study to compare transcatheter aortic valve replacement with open heart surgery in high risk patients. TAVR wins.

It’s only one study, but it’s perhaps telling that the theoretical advantages of a balloon-expandable transcatheter valve design seem to carry through into clinical reality as procedural success for Sapien XT significantly outstrips its rival CoreValve.

A combination of findings presented at ACC 2014 and a newly published clinical paper, point to a bleak future for Renal Denervation as a blood pressure reducing therapy, at least as far as Medtronic’s Symplicity System is concerned.

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