Companies

St. Jude Medical, Inc. has gained CE mark approval for a 25 mm iteration of its Portico™ Transcatheter Aortic Heart Valve Implantation System, extending the applicability of the device to more patients for whom transcatheter aortic valve replacement (TAVR) is indicated.

The prospect of removing an esophageal stent may be slightly daunting, but that’s what Cook Medical is investigating with a new US clinical study involving its supposedly retrievable new offering.

Newly cleared Harmonic Focus® + Shears with so-called Adaptive Tissue Technology promise accurate resection with consequent enhanced speed and surgical precision.

Could the FDA be about to approve a permanently indwelling, percutaneously inserted Left Atrial Appendage closure device? It’s hard to see the agency going against the 13:1 vote in favour from its expert panel.

Echo Therapeutics will receive a $10 million cash investment from MTIA and Platinum Partners as part of a new strategic collaboration that will see its interests in a chunk of the Far East devolved to MTIA.

Medtronic, Inc. is trumpeting the first-in-human implant of the world’s smallest pacemaker, called the Micra™ Transcatheter Pacing System. The device was implanted in a patient in Linz, Austria as part of the Medtronic global pivotal clinical trial.

Covidien plc is to acquire Israeli Pillcam® purveyor Given Imaging, Ltd. in a deal worth $860 million net of cash and investments.

Data presented at last week’s Cervical Spine Research Society annual meeting indicate that significant improvements in pain and functional outcomes achieved by 1.5 months in both groups were sustained at seven years.

Italian Cardiovascular device maker Sorin Group has gained CE Mark approval for its INTENSIA family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices, all of which feature a DF-4 high voltage connector.

New retrospective data presented at NANS 2013 this week show highly significant reduction in pain and high trial therapy success rate of Boston Scientific’s Precision Spectra in the treatment of chronic pain

Medtronic’s Activa® PC+S Deep Brain Stimulation System closes the loop in understanding the impact of this therapy, by monitoring the impact of the therapy on specific areas of the brain in real time.

St. Jude Medical, Inc., has initiated a clinical study of the Prodigy™ neurostimulator, the first spinal cord stimulation (SCS) system able to deliver a proprietary mode of stimulation therapy called burst stimulation. The SUNBURST™ study will evaluate whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation.

Biotronik, a pioneer in MRI compatible Cardiovascular implants devices, tells us that the US FDA has approved an expansion of its ongoing ProMRI® trial. This will allow inclusion of additional patient cohorts into the study, providing further support for the company’s proposed claims.

Italian Cardiovascular device company Sorin has confirmed that it has gained CE Mark approval and seen a first implant of the KORA 100 pacing system, which is MRI compatible.

These two OR household names have agreed to buddy up at a sales level. While coordinating their collective devices into one “turnkey” OR system makes a lot of sense, it’ll be interesting to see how their non-exclusive sales agreement works out in the field.

Last week we covered the news that Italian cardiovascular outfit Sorin had gained CE mark approval for its Solo Smart stentless heart valve. Now the company tells us it has also gained the European nod for the large sizes of its sutureless Perceval valve.