Smith & Nephew Inc’s Advanced Wound Management division announced the U.S. launch of its next Negative Pressure Wound Therapy product, the new RENASYS GO, designed to address the needs of clinicians and their active, mobile patients.
USA
Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: U.S. FDA Advisory Committee supports favorable benefit-risk profile of Bayer’s rivaroxaban
An Advisory Committee to the U.S. Food and Drug Administration met today to discuss the new drug application for Bayer’s rivaroxaban, a novel, oral anticoagulant taken as one tablet, once-daily for the prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
Edwards Lifesciences Completes Enrollment in Non-Surgical Study Arm of U.S. Clinical Trial for Transcatheter Valve
Edwards Lifesciences Corporation, the world leader in the science of heart valves, today announced completion of enrollment in the 350-patient non-surgical study arm of its U.S. pivotal trial — known as the PARTNER Trial — for the Edwards SAPIEN transcatheter aortic heart valve.
FDA Classifies Recent Urgent Device Correction on Baxter’s Colleague Infusion Pump as a Class I Recall
Baxter International Inc. announced today that the U.S. Food and Drug Administration has classified Baxter’s January 23, 2009 Urgent Device Correction letter to customers regarding U.S. COLLEAGUE® Volumetric Infusion Pumps as a Class I recall.
FDA Approves SyntheMed’s REPEL-CV® Adhesion Barrier for Use in Pediatric Cardiac Surgery
SyntheMed, Inc., a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that the U.S. Food and Drug Administration has approved the Pre-market Approval application for REPEL-CV® Adhesion Barrier for use in pediatric cardiac surgery patients.
North America Skull Base Society postpones annual meeting
The Board of Directors of the North American Skull Base Society has made the decision to postpone the annual NASBS meeting until October 2009
Hip Replacements Take A Big Step Forward: Anterior Approach Offers Fast Recovery, No Restrictions After Surgery
Increasing numbers of patients in North America are receiving hip and pelvis surgery that protects tissue, offers faster recovery, allows for more accurate placement of medical implants and reduces post-operation restrictions compared to traditional hip surgery.
Abiomed Appoints Michael Howley as Vice President and General Manager of Global Sales and Marketing
Abiomed, Inc., a leading provider of heart recovery products designed to recover hearts and eliminate in-hospital deaths from heart attacks and high risk percutaneous coronary interventions, announced today the appointment of Michael Howley as Vice President and General Manager, Global Sales and Marketing.
Bone Medical Receives Positive FDA Feedback On CaPTHymone™
Bone Medical Limited announced that it has had discussions with FDA on the US regulatory process for CaPTHymone™, Bone’s oral Parathoid Hormone product.
Arthrocare Device Use Draws More Scrutiny
An escalating FBI probe could pose new threats to embattled Arthrocare
Stryker probed on alleged payments to surgeons
The U.S. Justice Department is investigating whether Stryker Corp., the third-largest maker of artificial hips and knees, illegally paid surgeons to induce them to use company products, according to a court filing.
Medtronic awarded $250m damages in patent pcase
A federal jury found that Boston Scientific has infringed three patents owned by Medtronic
ArthroCare’s Device Sales Relationship PT II
Since surfacing two years ago, DiscoCare has boasted an uncanny ability to secure reimbursement for Arthrocare’s SpineWands.
Nasdaq Closes Review of ArthroCare
Nasdaq Closes Its Review of ArthroCare’s Prior Relationship With DiscoCare Unit
ArthroCare’s Device Sales Relationships Questioned
ArthroCare investors might want to read some past editions of The Palm Beach Post.