FDA Approval

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.

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.

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.

Insightra Medical has announced that its new Freedom inguinal hernia system has been cleared by the FDA. The device aims to address post-op chronic pain associated with traditional meshes by avoiding rigid fixation.

Spinal device company Baxano sees its minimally invasive spinal fusion technology platform expand with the FDA’s clearance of its iO-Tome™ instrument for precise facet joint removal.

Avery Dennison Medical Solutions has announced that it has received 510(k) clearance from the U.S. FDA for its new Chlorhexidine Gluconate (CHG) transparent film dressing, known as BeneHold™ CHG Transparent Film Dressing.

Last week the U.S. FDA issued its Pre-market Approval (PMA) for the Globus SECURE®-C Artificial Cervical Disc. Now the agency has issued its consumer information on the product which the company says outperforms anterior cervical discectomy and fusion.

Echometrix LLC has announced that it has received U.S. FDA clearance to market its EchoSoft™ ultrasound technology, which the company claims provides a new level of information from diagnostic ultrasound tests.

It’s looking like Boston Scientific Week with more news about launches or approvals. The FDA has approved Boston’s S-ICD® System, which we seem to remember triggers a big fat earn-out payment to Cameron Health following its acquisition earlier this year.

Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration clearance for the Emerge™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter and has begun marketing the device in the United States. The Emerge Catheter is a next-generation pre-dilatation balloon catheter designed specifically to offer exceptional deliverability for physicians to address challenging lesions in coronary arteries. Both the Monorail® and Over-The-Wire (OTW) options are available. The Emerge Catheter has been commercially available in CE Mark countries since earlier this year.
PR Newswire (http://s.tt/1ov7B)

Bolton Medical has announced the FDA’s approval of its Relay® Thoracic Stent-Graft with Plus Delivery System. The device is designed to address the needs of physicians performing minimally invasive surgery for thoracic aortic aneurysms and penetrating ulcers.