Companies

Boston Scientific Corporation has received CE Mark approval and has begun the European market launch of the Precision Spectra™ Spinal Cord Stimulator (SCS) System, the world’s first and only SCS system with 32 contacts and 32 dedicated power sources.

Covidien’s eV3 subsidiary business brought with it the Pipeline embolisation device when it was acquired. While the device shows encouraging results in patients with certain types of difficult-to-treat brain aneurysms, a new report suggests there are also reasons for some caution over fatal bleeds.

Medtronic, Inc. has gained CE Mark approval for its innovative Sentrino® Continuous Glucose Management System, the first minimally invasive continuous glucose monitoring system specifically designed for use in hospital critical care units.

The first patient has been enrolled in a Boston Scientific Corporation (NYSE: BSX) study comparing the WallFlex® Biliary RX Fully Covered self-expanding metal stent (SEMS) to plastic stents for the treatment of benign bile duct strictures caused by chronic pancreatitis.

Baxter International Inc. will acquire Swedish dialysis products company Gambro AB for a total consideration of a mere 26.5 billion SEK (approximately “a mere” $4.0 billion USD)

Covidien must be hoping surgeons will see the benefit of simplicity in its new meniscal repair device which has the retro feel of the twin needle gizmos we first saw twenty years ago.

Volcano Corporation has signed an agreement to acquire Crux Biomedical, a privately-held company that has developed a highly differentiated inferior vena cava (IVC) filter—the Crux VCF System—to treat pulmonary embolisms (PE’s).

Smith & Nephew plc is so keen to cement its place in wound care that it is acquiring bioactive debridement specialist company Healthpoint Biotherapeutics for $782 million in cash, which is reportedly over 4x revenue and 71x earnings.

St. Jude’s CE Mark for its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)brings to the market a family of devices featuring new algorithms, designed to help protect patients against inappropriate shocks.

Sorin’s investment in HighLife SAS will fund development of an innovative percutaneous mitral valve replacement technology, over which the Italian heart company will retain an option to buy.

St. Jude Medical, Inc. has announced the first patient implant of its 23 mm Portico™ Transcatheter Aortic Heart Valve using the Transapical Delivery System.

Boston Scientific will feel they have stolen some solid commercial ground with the news that, in Europe they can now claim extended life from their defibrillator ranges thanks to their new battery technology.

The FDA has published its inspection notes from recent visits to St.Jude’s Durata plant and they don’t make pleasant reading for the company. I dare say, if I was the FDA inspector and knew the history I might be a tad pedantic, but this lot reads like a catalogue of shortfalls.

Registry data collected from patients undergoing treatment with Wingspan under US Humanitarian device exemption approval has resulted in FDA issuing more limited indications for use. Yet in Europe we seem to be burying our heads in the sand on the device’s shortcomings.

J&J subsidiary, Cordis has seen its Incraft AAA stent graft study results reach 1 year with no problems and 100% efficacy. The graft, with its 13Fr delivery system aims to extend EVAR To More Patients than currently indicated.

Smith & Nephew plc has announced the appointment of Julie Brown as Chief Financial Officer. She will formally take up the post by early February 2013, when she will also be appointed to the Board as an Executive Director.