Companies

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.

Covidien plc has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.

Cook Medical has announced the Melker Cuffed Emergency Cricothyrotomy Catheter Set, a compact surgical set which it says is specifically packaged for performing Seldinger Cricothyrotomy procedures and ideal for smaller workspaces.

Abbott has announced the completion of enrollment of three clinical trials to support approvals of the company’s revolutionary Absorb™ Bioresorbable Vascular Scaffold (BVS) in the United States, Japan and China.

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).

Boston Scientific Corporation has received U.S. FDA clearance and CE Mark approval in Europe for the Expect™ Slimline (SL) Needle, which means it is now globally available for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA) procedures.

DePuy Synthes Power Tools has launched its “Next Generation”, 30% more powerful electric drill system for neurosurgery, otology and spinal procedures.

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.

St. Jude Medical, Inc., is trumpeting the U.S. FDA approval of its Protégé™ IPG, the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades to be made via software updates.

Cardiovascular device company Biotronik has announced that the first patients across the United States have received implants of the new Iforia implantable cardioverter-defibrillators (ICDs)

Cardinal Health has announced an agreement to acquire privately held extravascular closure device, AccessClosure, Inc., for $320 million, in a deal that is expected to close by early June 2014.

While Edwards Lifesciences and Medtronic slugged it out at ACC 2014 with studies comparing their TAVI (transcatheter aortic valve implantation)offerings, Boston Scientific draws our attention to new data presented at the event that says its own Lotus™ Valve System continued to demonstrate impressive performance at three months.

Orthopaedic giant, Biomet, Inc has released its quarterly financial statements showing a consolidated net sales increase of 7.5% on a constant currency basis, compared with the equivalent period a year ago. The growth comes on the back of a similarly healthy picture a quarter ago.

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.

Italian Cardiovascular device specialist Sorin Group tells us its Perceval™ sutureless aortic valve has received CE mark approval for adult age indication allowing treatment of a wider spectrum of patients with aortic stenosis and/or steno-insufficiency.