Abbott’s XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has received U.S. FDA approval and is to be launched immediately in the United States.
Companies
Covidien To Acquire Drug Coated Balloon Company CV Ingenuity
Covidien has announced a definitive agreement to acquire CV Ingenuity. The companies expect to complete the acquisition in the first calendar quarter of 2013.
Smith & Nephew Completes Healthpoint Acquisition
Smith & Nephew plc has completed the acquisition of substantially all the assets of Healthpoint Biotherapeutics for $782 million in cash, financed from Smith & Nephew’s existing cash resources and bank facilities.
Nanostim Breaks Cover: Leadless Cardiac Pacemaker Sees First Implants
Californian device company Nanostim, Inc., has announced the first successful implants of a leadless pacemaker in a series of 11 patients at Homolka Hospital in Prague, Czech Republic.
Urgent Worldwide Recall Of Zimmer’s PEEK Ardis® Interbody Spacer Inserter
Zimmer Spine, Inc. is initiating a voluntary worldwide recall of all 315 units of the PEEK Ardis® Inserter because of reports of implant breakage when the implant is subjected to excessive lateral and/or off-axis forces from the inserter during surgery.
Trial Results Suggest Biotronik Home Monitoring® Reduces Inappropriate ICD Shocks by 52%
A new paper, published in the European Heart Journal shows home-monitored patients experience 71% fewer delivered shocks and a 52% reduction in inappropriate shocks compared with a control group.
Who Owns Renal Denervation Part 2: The Plot Thickens
A therapy as potentially huge as renal denervation is bound to be tied up in claim and counterclaim, and downright confusion about who owns what. A new article tries to unpick it all.
One Year Symplicity™ HTN-2 Trial Results Show Sustained BP Reduction
Published data demonstrate the Symplicity™ renal denervation system provides blood pressure reduction in patients with treatment-resistant hypertension sustained to 12 months
First Patient In St.Jude’s ILUMIEN I Stent Guidance Study
St. Jude Medical, Inc. has announced the first patient enrollment in its ILUMIEN I clinical study, designed to show the way Optical Coherence Tomography can optimally guide stent implantation in patients with coronary artery disease.
Settlement Amounts Approved In Australian DePuy Litigation Suggest U.S. Settlements Approaching
Settlement amounts have been approved for the DePuy Hip Implant litigants in Australia, fueling hopes that U.S. settlements are nearing. The Australian National Joint Replacement Registry, which began reporting problems to DePuy in 2007, led the fight to have the devices removed from the market.
Boston Scientific’s Ingevity™ Pacing Lead Trial Sees First Patient
A first patient has been implanted with Boston Scientific’s new INGEVITY™ pacing leads in a clinical trial designed to establish the safety, performance and effectiveness of the leads.
Class I Recall For Ethicon’s SurgiFlo Due To Potential for Packaging Breach
Ethicon, a division of J&J, has identified an issue in the packaging process for its SurgiFlo haemostatic matrix. It seems certain products, manufactured between September 16 2011 and July 27 2012 are susceptible to a potential breach of the double Tyvek pouch of the packaging.
GE’s Infant Warmers To Integrate Covidien’s Pulse Oximetry Technology
GE Healthcare will be integrating Covidien’s Nellcor™ pulse oximetry with OxiMax™ technology into its Giraffe® and Panda® infant warmers, in a move which will help clinicians safely monitor infants for life-threatening and respiratory complications.
Misonix Terminates Distribution Agreement With Aesculap
Misonix says it is acting in a manner consistent with its business strategy by electing to sell its products under its own label via its own proprietary sales organization. With its now defunct distribution agreement less than 2 years old, Aesculap might be a little aggrieved.
Depuy Synthes Spine Unveils New Worldwide President
Johnson & Johnson’s DePuy Synthes Spine business has a new Worldwide president in the form of Max Reinhardt, a long term employee of the company and most recently Vice President of Worldwide Marketing.
FDA Approves EVARREST™ Fibrin Sealant Patch
Ethicon Biosurgery, has announced that the U.S. Food and Drug Administration (FDA) has approved EVARREST™ Fibrin Sealant Patch, a novel product that it says rapidly and reliably aids in stopping problematic bleeding during surgery.