Cook Medical has initiated enrollment in a U.S. clinical trial of its high-precision, next-generation Zenith® Low Profile AAA Endovascular Graft (Zenith AAA LP).
USA
St. Jude Medical Announces Initial Implant of First-to-Market Connector System in the U.S.
St. Jude Medical, Inc. today announced the first implant of its Current® Plus implantable cardioverter defibrillator (ICD), featuring the SJ4 connector system.
St. Jude Medical Completes Implants in U.S. Study of Deep Brain Stimulation for Parkinson’s Disease
St. Jude Medical, Inc. today announced the completion of patient implants in its U.S. pivotal clinical study of deep brain stimulation for the symptomatic treatment of Parkinson’s disease, a neurological disorder affecting approximately 6.3 million people worldwide.
Bone Solutions Inc. receives FDA 510(K) clearance for bone void filler, OsteoCrete
Bone Solutions Inc. announced today that it has received FDA 510(k) clearance for the first device in its technology pipeline—a proprietary bone void filler, OsteoCrete™.
Next-Generation Mechanical Heart Pump Implanted In Heart Patients
Three patients at NewYork-Presbyterian Hospital/Columbia University Medical Center were among the first in the United States to be implanted with a next-generation artificial heart pump called the DuraHeart™ Left-Ventricular Assist System.
Custom Spine Welcomes Randal Clarke as Vice President of Sales
Custom Spine announced today that Randal Clarke is the new Vice President of Sales for the U.S Western region.
Innovia LLC announced that it has received FDA 510(k) clearance to market the InnoPort™
Innovia LLC announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the InnoPort™ to facilitate single port access laparoscopy.
FDA Approves SBi’s S.T.A.R. Total Ankle Replacement System
Small Bone Innovations, Inc., a leading provider of innovation, products, technology and education for the small bone & joint segment of the orthopedics industry, announced today that the FDA has approved SBi’s Scandinavian Total Ankle Replacement (S.T.A.R.®) system to treat U.S. patients.
FDA Clears Boston Scientific’s SpyScope® Access and Delivery Catheter
Boston Scientific Corporation today announced that it has received FDA 510(k) clearance to market its SpyScope® Access and Delivery Catheter for diagnostic and therapeutic applications in the pancreatico-biliary system.
Drug-Eluting Stents More Effective Than Bare-Metal Stents In Heart Attack Patients
NewYork-Presbyterian Hospital and Columbia University Medical Center, together with the Cardiovascular Research Foundation, announced that its landmark study comparing the safety and efficacy of drug-eluting stents and bare-metal stents was published in the May 7 New England Journal of Medicine.
‘Beating’ Heart Machine Expedites Development Of New Surgical Tools, Techniques
A machine developed at North Carolina State University in Raleigh may allow researchers to expedite development of new tools and techniques for heart surgery.
FDA Approves Boston Scientific’s Next-Generation TAXUS® Liberte® Atom™ Stent System
Boston Scientific Corporation today announced it has received approval from the U.S. Food and Drug Administration to market its TAXUS® Liberte® Atom™ Paclitaxel-Eluting Coronary Stent System.
BSD Medical Names Steven Smith as Vice President of Marketing and Business Development
BSD Medical Corporation announced today that Steven M. Smith has been appointed Vice President of Marketing and Business Development.
Archus Orthopedics cuts staff, scales back operations
Archus Orthopedics, a Redmond company developing reconstructive implants for spine disorders, has “substantially” reduced its headcount and scaled back operations, according to Chairman and CEO Jim Fitzsimmons.
Medtronic Announces U.S. Trial Of Unique Therapy For Closure Of The Left Atrial Appendage
Medtronic, Inc. announced the successful implant of its Cardioblate Closure Left Atrial Appendage Occlusion Device as part of a U.S. clinical trial.
FDA to Review Its Approval of Knee Device
The Food and Drug Administration said it will re-examine its decision to approve a knee-surgery device last December over the objections of several scientists and managers at the agency, according to a letter from the FDA that the Senate Finance Committee reviewed Monday.