Companies

DePuy Synthes Spine has received FDA 510(k) clearance for use of its EXPEDIUM®(pictured), VIPER®, and VIPER®2 Spine Systems on patients with adolescent idiopathic scoliosis (AIS), expanding the scoliosis indication for the pedicle screw systems, previously only approved in adults.

Financial key performance indicators for S&N’s quarter, when set against the equivalent period a year ago show revenue of $1,029 million, up 2% on an underlying basis, trading profit of $234 million, up 6% on an underlying basis, with trading profit margin up 80 bps to 22.7% as Advanced Surgical Devices (ASD) division restructuring benefits come through

Covidien has announced FDA 510(k) clearance to market its Covidien Nellcor™ Bedside SpO2 Patient Monitoring System.

Boston Scientific Corporation has received CE Mark approval for use of its MRI compatible INGENIO™ and ADVANTIO™ pacemakers

Medtronic, Inc. has announced the FDA 510(k) clearance for its Aquamantys®3 BSC 9.1S Bipolar Sealer with Cutting, a new addition to the orthopaedic portfolio of the company’s Advanced Energy business. Combining sealing with cutting in a single device should make procedures more efficient, according to the company.

Georgia’s Mimedx Group is a developer of biomaterial solutions for surgical repair of soft tissues using human amniotic membrane. Pretty specialised field and never likely to be sponsoring the Olympics, but nonetheless the company’s recently stated Q2 financials suggest it’s in good shape, having grown consistently and turned red numbers black in the past twelve months.

Hill-Rom has completed its acquisition of Aspen Surgical Holdings in a move which the Batesville, Indiana outfit believes will enhance its presence in the surgical products market.

Codman Neurovascular, Inc., has announced the launch of the DELTAMAXX™ Microcoil System, ORBIT GALAXY® G2 Microcoils, and ENVOY DA Guiding Catheter at this year’s SNIS meeting in San Diego.

Cook Medical has announced general availability of the Aprima Access Nonvascular Introducer Set, the first product in the Aprima drainage portfolio. The system is purpose-designed for nonvascular single-puncture percutaneous access to facilitate placement of a working wire guide for interventional radiology procedures.

Edwards Lifesciences Corporation has released its second quarter financial results which are, on face value, bucking the trend by showing sales growth of almost 16% (albeit excluding currency impact) to $482m compared with the equivalent period last year. Closer examination reveals that growth is almost exclusively related to the company’s Sapien transcatheter heart valve, launched in U.S and seeing continued growth internationally.

Siemens Healthcare has announced that its MAGNETOM Spectra 3 Tesla MRI system has received US FDA clearance. The company believes it has achieved the optimal blend of reduced ownership costs, excellent image quality and rapid scan times with this system which it says provides hospitals and radiological institutes with easier access to 3T technology.

Breg, Inc., has announced the appointment of Stuart M. Essig as chairman of the board. Mr. Essig retired from the position of Chief Executive Officer at Integra LifeSciences Holdings Corporation earlier this year.

St.Jude’s CEO Dan Sparks used the word “favorable”(sic) to describe the outcome from its giant study into whether closure of a patent foramen ovale using the company’s Amplatzer device has a positive impact on incidence of cryptogenic stroke. Some commentators are suggesting he should have kept schtum until the clinical results are published later in the year.

Baxter International Inc. has announced financial results for the second quarter and confirmed its full-year 2012 financial outlook. Sales increase of 4% year-on-year coupled with 1% income hike is in line with previous guidance.

Biotronik has announced that the first cardiac resynchronisation therapy device (CRT-D) patient has been enrolled in its so-called EuroEco Trial—the European Health Economic Trial on Home Monitoring in implantable cardioverter-defibrillator (ICD) and CRT-D patients.

There’s no stopping Covidien’ s neurovascular clot retrieval device, which the company has announced can now add Brazil to Europe and USA as territories wher eit is approved for sale.