Ethicon Endo-Surgery has launched its HARMONIC ACE®+7 Shears with Advanced Hemostasis, the first purely ultrasonic device with a 7 mm sealing indication. It claims the system outperforms its rival LigaSure™device when it comes to burst pressure.
Johnson & Johnson
J&J Suspends Sales of Power Morcellators Over Cancer Spreading Risk
A Reuters article tells us that Johnson & Johnson has suspended the sale of its power morcellators until the risk of spreading cancerous cells is better understood. This in response to earlier FDA guidance on the subject.
New Mandible Plate “Seamlessly Integrates Surgical Planning, Intraoperative Tools and Patient Specific Devices
DePuy Synthes CMF has launched its new Patient Specific Plates for Mandible surgery, bringing a new level of accuracy to the procedure and avoiding the risk of bending-induced plate breakage.
Mitralign Catheter-based Mitral Valve Repair EU Study Completes Enrollment
Cardiac device company Mitralign Inc., has completed enrollment in a European study to investigate the performance of its simple, but clever system of cinched anchors in patients with functional mitral regurgitation (FMR).
First FDA Approval for Contact Force-Sensing Atrial Fibrillation Ablation Catheter
Contact force-sensing has become something of a buzz word in cardiac ablation as the benefits of being able to avoid too much or too little contact become apparent. Now Biosense Webster has become the first to get its contact force sensing catheter FDA approved.
Renal Denervation Systems Still Getting CE Marked for Resistant Hypertension
It’s been pretty quite in Renal Denervation territory since the January bombshell of Symplicity HTN-3 clinical outcomes. Nonetheless, one company, Cordis, has pushed ahead with its CE marking and now been granted its EU approval.
Cordis to Distribute Chocolate®
TriReme Medical has signed a broad distribution agreement with J&J’s Cordis Corporation for the exclusive distribution of the Chocolate PTA balloon catheter, with an option for additional TriReme portfolio products.
Aneurysms Holding at 2 Years in Cordis INCRAFT® AAA Stent Graft Study
J&J Subsidiary, Cordis Corporation has seen two-year data from its INNOVATION Trial presented at the 2014 Leipzig Interventional Course in Germany. Data from the study continues to demonstrate that the INCRAFT® System performs well in patients suffering from abdominal aortic aneurysms (AAA) two years after treatment.
IFU Changes Mean Codman Neuro’s TRUFILL® n-BCA Liquid Embolic System Gets Class I Recall Status
Codman Neuro has announced changes to the instructions for use for its TRUFILL® n-BCA Liquid Embolic System. It seems incorrectly mixed product can result in embolization or reflux, which has lead the U.S. FDA to label the company’s medical device correction notice as a Class I recall.
J&J Device Sales Grow
Johnson & Johnson has unveiled its Q4 figures which show an impressive 4.5% increase over the equivalent period a year ago. That’s not a bad return when we’re talking about $18.4 billion for one quarter. Figures include net impact of Synthes acquisition and DePuy Trauma divestiture.
J&J Offloads Ortho-Clinical Diagnostics Business for $4Bn+
In a deal worth $4.15 billion, private equity company The Carlyle Group is to acquire Johnson and Johnson’s Ortho-Clinical diagnostics business, signalling J&J’s departure from in-vitro diagnostic services business.
Device Alert for Upside Down Vena Cava Filter
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a device alert relating to certain lots of OPTEASE® retrievable vena cava filter, manufactured by J&J’s Cordis Corporation.
FDA Clears Ethicon-Endo’s New Harmonic Focus®+ Shears With Adaptive Tissue Technology
Newly cleared Harmonic Focus® + Shears with so-called Adaptive Tissue Technology promise accurate resection with consequent enhanced speed and surgical precision.
Ethicon Reality Checks into Collaboration with Megadyne®
Ethicon Endo-Surgery, Inc. and Megadyne®, Inc have both issued press releases, confirming that they have entered into a collaboration agreement. The deal will see customers offered a contracting solution that incorporates the two companies’ combined product offerings, increasing choice and access to a broad energy portfolio.
Mitek Sports Medicine Unveils Anatomic ACL Reconstruction Portfolio
It’s been thought for over a decade that use of the anteromedial(AM) portal in ACL reconstruction is the best way of achieving an anatomical femoral socket, compared with drilling it through the tibial tunnel. Mitek sports medicine is showcasing its new purpose-designed Rigidfix® arc which facilitates Rigidfix cross pin fixation using the AM approach.
Johnson & Johnson Considering $3 Billion Settlement of DePuy Hip Implant Lawsuits
Johnson & Johnson is considering a settlement with injured hip implant patients that could total more than $3 billion. Sources close to the matter have told Bloomberg that the company is weighing their options in settling thousands of cases involving DePuy hip implants that have been linked to early failure rates and a host of serious complications.