Covidien has announced the start of enrollment in two clinical trials that it says further underscores the safety and effectiveness of the company’s advanced neurovascular solutions.
Companies
Abbott’s Dissolving Heart Stent Performs as well as Metallic Comparator at One Year
Newly presented study findings provide reassurance that performance of Abbott’s fully absorbable coronary stent is equivalent to its metallic forebeer at one year.
CE Mark and First US Implant for Medtronic’s Re-Sheathable CoreValve
Medtronic has gained CE Mark approval for the 23 mm CoreValve® Evolut™ R TAVI System and has seen the device’s first implantation in its U.S. study.
Transvaginal Mesh Lawsuit “will be the largest product liability settlement in history”
Legal-Bay LLC, tells us that a Federal Jury in West Virginia has awarded a husband and wife $3.27 million in damages against Ethicon, Johnson & Johnson’s mesh product division in what is another loss for transvaginal mesh manufacturers
Codman Neuro Expands Aneurysm Portfolio with PulseRider® Distribution Deal
J&J’s Codman Neuro tells us it has entered into an exclusive distribution agreement with Pulsar Vascular to market and promote the PulseRider® wide neck aneurysm device in Europe, the Middle East and Africa.
Whistleblower Gets $2.3 Million of $11 Million Smith & Nephew Settlement
A former S&N employee has ultimately scored pretty highly with life-changing winnings from whistleblowing on the illicit behaviour of his former employer.
Codman Neuro’s REVIVE™ SE Thrombectomy Device Approved in China, South Korea and Taiwan
J&J’s Codman Neuro has gained a clutch of Far Eastern regulatory approvals for its REVIVE™ SE Thrombectomy Device for restoring blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease.
New Spine Boss at Integra LifeSciences
Integra LifeSciences Holdings Corporation has announced that Mark Augusti has joined Integra as CVP, President, Orthopedics and Tissue Technologies in a role that will see him head up the company’s Spine and Extremities divisions.
Study Confirms Fractional Flow Reserve Measurement Drives NSTEMI Treatment Strategy
Newly presented data says that using FFR measurement technology changed the course of treatment for more than one fifth of patients suffering non-ST segment elevation myocardial infarction (NSTEMI) heart attacks.
Vagus Nerve Stimulation Study Misses Primary Efficacy Endpoint, But QOL Improved
It’s good news/bad news for Boston Scientific’s Vagus Nerve Stimulation plans as a heart failure therapy. While efficacy endpoints suggested no outcome improvement, patients in the treatment group of the sham controlled study reported quality of life improvement.
Comparative Study Supports St. Jude Quadripolar Leads vs Bipolar
St. Jude claims its Quadripolar pacing system set the standard and a newly presented study is a strong addition to the more than 100 publications supporting the argument.
FDA Clears Medtronic SHILLA™ Growth Guidance System
Medtronic has gained U.S. FDA 510(k) clearance for its SHILLA™ Growth Guidance System, designed to treat spinal deformities in skeletally immature pediatric patients with severe, progressive, life-threatening, early-onset spinal deformities.
DePuy Synthes Craniomaxillofacial Distraction System Recall is Class I
When a device is relied on to provide distraction, it’s obviously alarming when it has the potential to reverse direction. The consequences are significant enough to warrant the FDA classifying Depuy Synthes’ recall as Class I.
Ethicon Unveils Expanded Bariatric Surgery Portfolio at IFSO 2014
Ethicon is introducing three new endocutter and energy products at the 19th World Congress of International Federation for the Surgery of Obesity & Metabolic Disorders (IFSO 2014).
Medtronic Bolts on Sapiens Steering Brain Stimulation for $200 Million
Medtech Titan Medtronic has acquired Dutch Neuro device developer and its novel Deep Brain Stimulation system
FDA Approval for Medtronic Viva® Cardiac Resynchronization Therapy-Pacemaker
CE marked earlier in the year, Medtronic’s Viva CRT-P system will now be available for US patients following its newly announced FDA approval.