PEAK Surgical, Inc. today announced the launch of the PEAK® PlasmaBlade TnA (Tonsil and Adenoid) tissue dissection device following 510(k) clearance from the U.S. Food and Drug Administration (FDA).
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New Collagen Meniscus Implant Opens New Vista for Knee Repair
The Stone Clinic in San Francisco reported it implanted the first commercially available meniscus templates in California this past week, opening up a whole new field of meniscus reconstruction.
PEAK Surgical Announces First Use Of PEAK PlasmaBlade In Europe
PEAK Surgical, Inc., today announced the first use of its PEAK® Surgery System by surgeons in the European Union.
Total Artificial Heart Bridges People Rejecting Donor Hearts To 2nd Transplant
During 2008, 10% of people who were implanted with the SynCardia temporary CardioWest™ Total Artificial Heart received the device because they were suffering from rejection of their donor heart transplant.
Onset Medical Receives European CE Mark Approval for the SoloPath Endovascular Access Catheter
Onset Medical Corporation announced today the Company has received CE Mark approval to begin marketing the Company’s SoloPathTM Endovascular Access Catheter in the European Union.
Cook Medical’s New Zenith® TX2® TAA Endovascular Graft With Pro-Form Enhances Control During Thoracic Aneurysm Repair
Physicians can now achieve even greater levels of control during endograft deployment with Cook Medical’s new Zenith® TX2® TAA Endovascular Graft with Pro-Form.
Lutonix, Inc. Announces First Patient Enrollments In Three Separate Clinical Trials
Lutonix, Inc., a privately held medical device start-up, announced that patient enrollment is underway for its three simultaneous first-in-human clinical trials.
Orthofix International Announces Development & Marketing Agreement with Stout Medical Group
Orthofix International announced today that the Company has signed a License and Product Development Agreement with Stout Medical Group, LP for the development and marketing of a new expandable vertebral body replacement (VBR) and corpectomy device.
Orthofix International Receives CE Marking For Advent™ Cervical Disc
Orthofix International N.V. announced that the Company has received CE Marking for its Advent™ Cervical Disc, allowing it to begin selling the new device in Europe.
Atrium Medical Corporation Announces Release of the Interim Results of the “COCTAIL Study”
Atrium Medical Corporation is proud to announce the release of the interim results of the “COCTAIL Study.”
Spectranetics Announces First Human Uses of Turbo-Tandem System
Spectranetics Corporation today reported the first human procedures using its Turbo-Tandem™ System, which had earlier received FDA clearance and CE mark approval for marketing in the US and the EU.
KCI Appoints Michael Genau to New Global Leadership Position To Expand Current Wound Therapy Division
Kinetic Concepts, Inc. announced today that Michael Genau has joined the Company in the newly formed position of Global President, Wound Therapy.
Life Spine® Announces FDA Clearance Of FS3 Minimally Invasive Spinal System
Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the FS3 Minimally Invasive Spinal System.
CardioFocus Receives CE Mark For Atrial Fibrillation Ablation Catheter
CardioFocus, Inc. announced that it has received a CE Mark allowing the company to commence European marketing of the Endoscopic Ablation System (EAS) to treat patients with atrial fibrillation.
K2M Launches CASPIAN Spinal System To Address Cervico-Thoracic Pathologies
K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced the launch of the CASPIAN™ Spinal System.
Study Finds Edwards Lifesciences’ Port Access System Facilitates Improved Outcomes Compared to Sternotomy
Edwards Lifesciences Corporation announced that new research demonstrates that using its minimally invasive PORT ACCESS System in mitral valve surgery significantly improves outcomes when compared to conventional sternotomy.