Zimmer’s newly launched DTO 5.5 System enables clinicians to treat varying levels of spinal disc degeneration at adjacent levels, seamlessly integrating fusion and non-fusion treatments through a single construct.
Companies
$3.35M Award For Nurse In J&J Vaginal Mesh Case
J&J should pay a South Dakota nurse $3.35 million according to the jury in the much-reported vaginal mesh trial. They found that the company had failed to provide adequate warning of risks to the plaintiff’s doctor. J&J’s rebuttal to follow.
FDA Clears New Sizes Of Resolute Integrity Coronary Stent For Long Lesions Common Among Diabetes Patients
Medtronic, Inc. has announced that the U.S. FDA has approved the 34mm and 38mm lengths of the Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm and 4.0mm. The longer lengths include an indication for patients with diabetes in whom longer lesions are common.
FDA Approves First Single-Lead ICD with Atrial Sensing
Biotronik has announced the FDA approval of its Lumax 740 DX System. This novel device is a first-in-class implantable cardiac defibrillator (ICD) that utilizes a single lead with atrial sensing capabilities.
New President And CEO For Tornier
Orthopaedic device company Tornier, N.V. has announced that its Board of Directors has appointed David H. Mowry as President and Chief Executive Officer, effective immediately.
Kransky vs DePuy: Chromium Didn’t Poison Patient Says Toxicologist
So did chromium from wear particles in DePuy’s ASR hip system poison Mr Kransky? A prominent toxicologist says no, but then his work is undermined by the plaintiff’s attorney who implies bias. It’s feisty stuff.
FDA Class I Recall As DePuy’s LPS Diaphyseal Sleeve May Not Accommodate Physiologic Loads
The FDA has issued a Class I recall of DePuy’s LPS Diaphyseal Sleeve the company having found that the Sleeve to its Base taper connection may not be sufficient to accommodate potential physiologic loads under some circumstances.
OrbusNeich Alleges Boston Scientific Infringes Some Of Its EU Stent Patents
OrbusNeich alleges that Boston Scientific has infringed two European patents covering certain novel stent designs. It claims two patents are infringed by several of Boston Scientific’s coronary stent systems, including the “PROMUS Element™”, “PROMUS Element™ Plus”, “OMEGA™ PtCr”, and “TAXUS™ Element™”.
Small, MRI Compatible And With Remote Monitoring: What’s Not To Like About Biotronik’s Newly CE Marked Ilesto 7 ICD/CRT-D Devices?
Biotronik has announced that its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series has received CE approval. The device family includes the one of the world’s smallest ICDs and is MRI compatible as well as being equipped with Biotronik Home Monitoring® technology.
New St.Jude Study To Explore Effects Of Renal Denervation On The Heart
“Super therapy” renal denervation may favourably impact major cardiac events and a new study hopes to demonstrate to what extent. We’ll be fascinated to see the results and are betting the house on the fact that there is a positive effect.
Does Medtronic Have EndoGraft Company In Its Sights?
Medtronic, the global leader in the $2 billion per year fast growing Aortic Endografts Market is rumoured to be about to increase its stake by acquiring new paradigm shifting technology that addresses the under-served needs of patients thoraco-abdominal aneurysms
FDA Nod For Medtronic’s New MRI-Friendly Pacing System
Medtronic has gained FDA approval and will commence U.S. launch of its Advisa DR MRI™ SureScan® pacing system. The system is Medtronic’s second-generation MR-Conditional pacemaker and is the first to combine the most advanced pacing technology with proven MRI access.
FDA Class I Recall For St. Jude’s Amplatzer™ TorqVue FX Delivery System
St.Jude’s Amplatzer PFO device has its own dedicated delivery system, called Amplatzer “TorqVue”. It seems there is a problem with the core wire on certain batches, all of which are now subject to an FDA class I recall.
J&J’s Ethicon Unit Faces Uphill Battle In New Jersey Transvaginal Mesh Trial, Says Legal-Bay LLC
The Lawsuit Settlement Funding Company, which has been a public advocate for women victims of various vaginal and pelvic mesh implants, reported today that industry insiders close to the Ethicon Prolift mesh trial have advised them that the plaintiff’s case has raised serious concerns as to what J&J knew about the dangers of their mesh products.
Biotronik Home Monitoring®: Study Says It Eases Clinical Routine
Findings from a newly published study suggest that as well as improving patient care, remote monitoring using Biotronik’s proprietary system also takes pressure of the clinical routine.
Sports/Extremity/Trauma Underpins Biomet Q2 Revenue Growth
Even without the revenue following the acquisition of DePuy’s trauma business, Biomet’s SET products showed impressive double digit growth. Joints nudged up too, but it’s SET that has underpinned the company’s positive sales momentum.