Stryker Corp. has received a subpoena from the Attorney General of New Jersey related to an investigation of financial relationships between companies that make medical products and surgeons that use them.
USA
Article Reports Fewer Repeat Procedures With Boston Scientific’s TAXUS® Liberte® Stent
Journal of American College of Cardiology reports fewer repeat procedures with Boston Scientific’s TAXUS® Liberte® Paclitaxel-Eluting Stent compared to patients treated with ‘olimus-based drug-eluting stents.
St. Jude Medical Announces FDA Approval of Current Plus ICD and Promote Plus CRT-D Devices
St. Jude Medical, Inc. today announced U.S. Food and Drug Administration approval of the Promote® Plus cardiac resynchronization therapy defibrillator and Current® Plus implantable cardioverter defibrillators.
Covidien Announces Definitive Agreement to Acquire VNUS Medical Technologies, Inc.
Covidien and VNUS Medical Technologies, Inc. today announced that Covidien has reached a definitive agreement to acquire VNUS, a developer of medical devices for minimally invasive treatment of venous reflux disease.
Edwards Lifesciences Receives FDA Approval for New Heart Valve
Edwards Lifesciences Corporation, the world leader in the science of heart valves, today announced that it has received approval from the U.S. Food and Drug Administration for the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, designed for easier implantation in the heart.
CoreSpine Technologies™ Receives Clearance To Market Surgical Disc Preparation Device
CoreSpine Technologies announced today it has received 510(k) clearance to market from the U.S. Food and Drug Administration for its XTEND-ST™ Nucleus Removal System.
Medtronic Introduces The PEEK PREVAIL Device for Neck Surgery
Medtronic, Inc. today announced the U.S. launch of the PEEK PREVAIL™ Cervical Interbody Device.
ISTO Technologies, Inc. Announces FDA Approval to Initiate a Clinical Trial for a Novel Treatment for Disc Nucleus Regeneration
STO Technologies, Inc. announced today that it has received notification from the U.S. Food and Drug Administration allowing the company to proceed with a Phase I clinical study for NuQu™, a cell-based injectable formulation of juvenile chondrocytes designed to regenerate cartilage, restore disc function and relieve discogenic back pain.
Core Essence Receives FDA Approval For SECURUS™, An Innovative Knotless Suture Anchor System
Core Essence Orthopaedics, Inc. announced that it has received 510(k) regulatory approval from the Food and Drug Administration for SECURUS™, a novel knotless suture anchor system used in minimally invasive, arthroscopic surgery.
Berlin Heart Receives First Regulatory Approval In North America
Berlin Heart GmbH announced it has received its first marketing approval in North America, for the EXCOR® Pediatric ventricular assist device.
LDR Announces FDA Clearance of Its ROI-A ALIF Device
LDR, a total spine solution company, announced that it received FDA clearance on Feb. 2 to market its ROI-A™ implant as an anterior lumbar interbody fusion (ALIF) device.
Abbott Initiates U.S. Study of Absolute Pro™ Peripheral Stent System for Iliac Artery Disease
Abbott today announced the initiation of MOBILITY, a clinical trial studying the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in patients with iliac artery disease.
U.S. advisers reject wider Stryker bone putty use
Stryker Corp’s bone-growth putty for spinal surgery should not be approved for expanded use in a wider population, advisors to federal drug regulators said on Tuesday.
Gore Receives FDA Approval For Larger Diameter, Small Profile AAA Endoprosthesis
W. L. Gore & Associates announced that it has received approval from the US Food and Drug Administration to market a 31 mm diameter version of the GORE EXCLUDER® AAA Endoprosthesis.
Millennium Research Group Predict Rapid Growth Of US Spinal Nonfusion Procedures
According to Millennium Research Group’s new US Markets for Spinal Implants 2009 report, the US spinal nonfusion technology segment will see an increase in procedure volumes through 2013 largely at the expense of traditional spinal fusion.
Covidien Receives FDA Clearance For New Pulse Oximeter With OxiMax SPD™ Alert
Covidien announced today that the United States Food and Drug Administration has issued a 510(k)marketing clearance for the Nellcor™ OxiMax™ N-600x™ pulse oximeter with OxiMax SPD™ alert.