Regulatory

AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, has received European CE Mark approval for AeroForm™, a needle-free, patient-controlled tissue expansion system.

FDA clearance of Medtronic’s Affinity Pixie® Oxygenation system provides Perfusionists with options for a broader range of patients. The system was CE marked in May 2010 so won’t be new to Europeans.

NuVasive, Inc., has reported having a good week at NASS2012, culminating with the news that the U.S. FDA has granted Premarket Approval for the PCM® Cervical Disc System.

Clever non-invasive glucose monitor measures levels using light. The device is now CE marked for use as an adjunct to conventional invasive techniques.

Ethicon endo’s voluntary recall of certain Proximate Circular staplers during the summer has turned in to an FDA Class I recall due to the serious consequences that can befall the patient in whom the stapler has not completely fired.

Osseon® Therapeutics, Inc. announced today the commercial release in the U.S. of its newest product, the Osseoflex® SB steerable inflatable bone tamp. After successful launch and distribution in Europe, the Osseoflex SB has received FDA clearance for sale in the U.S.

CardioKinetix’s Parachute ventricular partitioning device has had its CE mark extended to include a full range of sizes, opening up percutaneous ventricular restoration therapy to a wider range of patient anatomies.

The theory is based on sound principles. Insert a coronary stent that is able to expand to adapt to changing vessel size and it will be more effective as the vessel dilates and clot dissolves. Now FDA’s approval of an IDE study will allow Stentys to back its claims.

FDA approval confirms that ExAblate® MRI-guided Focused Ultrasound is effective in reducing pain from bone metastases in patients who could not undergo radiation therapy.

The new stand-alone indication for Integra’s Vu aPOD™ Prime Intervertebral Body Fusion Device means the device has extended utility in anterior lumbar interbody fusion procedures.

And we thought the Eurocrat life was a dull one. Commissioner Dalli goes from issuing new medical device directives to resigning over alleged involvement in a Swedish tobacco legislation fraud case in a matter of weeks.

Integra LifeSciences Holdings Corporation has announced the launch of the Integra® CUSA® NXT Inferior Forward Bone Tip for its CUSA® NXT Ultrasonic Tissue Ablation System.

Such is the buzz around transcatheter heart valve replacement that the FDA has seen fit to issue a press release giving its own interpretation of the approval issued to Edwards’ Sapien valve for patients considered high risk for conventional surgery.

Edwards Lifesciences’ long wait for an extended indication for its Sapien Valve is over with the news that FDA has rubber stamped the guidance from its summer expert circulatory panel meeting.

The U.S. FDA has granted a Premarket Approval (“PMA”) Order for Paradigm Spine’s Coflex®, a minimally invasive, Motion Preserving Interlaminar Stabilization™ device for the treatment of Moderate To Severe Stenosis With Or Without Back Pain™.

Loma Vista Medical says its World first ultra-precise balloon is specifically designed to prevent balloon ruptures in TAVI and BAV procedures. Catch it at TCT 2012.