Medtronic

Medtronic, Inc. has announced the U.S. launch of its Export Advance aspiration catheter, which it says offers greater power and superior deliverability in coronary artery thrombus removal.

In a guest editorial, author Whitney Taylor from Injury Lawyer News writes about the current state of play in the long running saga of Medtronic’s Infuse Bone Graft.

The U.S. FDA’s Circulatory Systems Devices Advisory Panel has narrowly voted (4 vs 3 with one abstention) that biventricular (BiV) pacing with Medtronic, Inc. devices is beneficial for treating patients who have atrioventricular (AV) block and left ventricular (LV) systolic dysfunction, compared to conventional right ventricular pacing.

Medtronic, Inc., a world leading spinal technology company, has taken the opportunity presented by two big spinal congresses to announce the CE marking and European launch of a new cervical cage system which expands the successful Compact CORNERSTONE-SR® platform of cages.

Peripheral Vascular Stent options in the US now include Medtronic’s Complete SE offering which has seen its indication extended to include the superficial femoral and proximal popliteal vessels.

Cardiovascular technology company Volcano Corporation has signed an agreement to acquire the Pioneer Plus™ diagnostic ultrasound transducer and percutaneous catheter from Medtronic, Inc. in a transaction that is expected to close by the end of August.

Edwards Lifesciences Corporation announced that the injunction against sales of Medtronic’s transcatheter heart valves in Germany had gone into effect. In a magnanimous gesture, Edwards is allowing for exceptions where its own Sapien valve is not indicated, but Medtronic’s CoreValve is.

Medtronic has posted financial results for its first quarter of fiscal year 2014, ended July 26, 2013. It’s forecasts for revenue and EPS for FY 2014 remain as stated in last year-end financials, although sales estimates were a smidge lower than anticipated by analysts.

So, five years after first getting a CE mark nod, Medtronic now has enough data to support its peripheral angioplasty balloon as far as module 1 of a PMA submission. Did EU regulatory authorities jump the gun too early or was the US hurdle too high for Invatec ’til Medtronic came along?

Medtronic, Inc. has announced the closing of the acquisition of Cardiocom, a privately held developer and provider of integrated telehealth … continue reading “Medtronic Buys Cardiocom in Broader “Healthcare” Initiative”

Australia’s regulatory authority, the Therapeutic Goods Administration (TGA) has issued a hazard alert pertaining to one of Medtronic’s pacing devices, the Consulta Cardiac Resynchronization Therapy Pacemaker (CRT-P). The action coincides with the company’s recall of certain Consulta and Syncra CRT-P devices.

Medtronic has issued a press release relating to a the ruling by a court in Mannheim Germany that its CoreValve® Transcatheter Valve System infringes a patent owned by Edwards Lifesciences. Suffice it to say they’re not happy.

Medtronic, Inc. has announced the global market introduction of the CD HORIZON® SOLERA® Spinal System Sagittal Adjusting Screw (SAS) which … continue reading “Medtronic’s New Screw for Medtronic’s CD HORIZON® SOLERA® Spinal System Offers Enhanced Positioning”

Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories. These have been wrapped up into one Device Alert by the UK’s MHRA regulatory authority.

Medtronic, Inc. has announced the first patient enrollments in the U.S. Overnight Closed Loop Study, a key feasibility trial to begin the commercialization path for a third-generation, fully automated artificial pancreas system for people with diabetes.

Medtronic, Inc.  today issued a press release in which it acknowledged the publication of the findings from Yale University’s third-party, … continue reading “INFUSE® Bone Graft Review Leaves Questions”