Companies

It’s AAOS week, and Mitek Sports Medicine has chosen the event for the launch of the MILAGRO® Advance Interference Screw, a new biocomposite screw designed to offer easier and faster insertion when compared to traditional interference screws.

In short What a peculiar and unusual series of events the final throes of MitraClip’s progress to FDA approval have … continue reading “FDA Panel Not Unanimous On MitraClip, But Approval Likely”

The Left Atrial Appendage is a troublesome little design feature. It doesn’t appear to possess any purpose and can be the source of clots, especially in AF patients, leading to an attendant stroke risk. So let’s block it off? Eu regulators seem happy with that idea, U.S. less so, which again shows up our differences.

Ethicon Endo-Surgery, Inc. has announced the 510(k) clearance from the U.S. FDA for its ENSEAL® G2 Cordless Tissue Sealer Device. Already previously approved in a variety of iterations, the new cordless design is clearly pitched at procedures where speed and range of motion may be critical.

Newly published data indicates St. Jude Medical Trifecta Heart Valve closely resembles the hemodynamic performance of a natural, healthy heart valve

FDA’s reading material, issued in advance of today’s PMA review meeting are not recommending the approval of the MitraClip implantable heart device, citing a lack of “valid scientific evidence” of safety and effectiveness. And a lack of comparator group.

Ex-staffer Brad Mason returns to Orthofix as President and Chief Exec, filling the shoes of the outgoing Robert Vaters.

Stryker has announced the launch of the its ES2 Spinal System. The company says ES2’s streamlined implant and instrument design allows for one-step, percutaneous placement of the screw and retractor, providing surgeons with the efficiency, simplicity and security they desire during minimally invasive procedures.

Case number 2. Only 10,748 to go. This time its Chicago and one Carol Strum vs DePuy. Early shots suggest they’re aiming at punitive damages based on the assertion that DePuy knew of the design flaws in its product before Ms Strum had one implanted in her.

Steven Ek has been named ArthroSurface’s President and Chief Executive Officer, effective November 20, 2012. Mr. Ek is one of the original founders in Arthrosurface and a Director since inception.

J&J company Cordis Corporation, has announced it has completed the acquisition of Flexible Stenting Solutions, Inc., a leading developer of innovative flexible peripheral arterial, venous and biliary stents. Terms of the deal have not been disclosed at this time.

Stryker Corporation has announced that its Instruments division has received a warning letter from the U.S. Food and Drug Administration … continue reading “FDA Sends Stryker Warning Letter Over Marketing Practices”

Law firm, Legal Bay has issued this release following the jury’s massive award to Loren Kransky, plaintiff against J&J DePuy. It’s predicting many many more such cases.

Loren Kransky has been awarded over $8M in his lawsuit against J&J Depuy over the ASR hip prosthesis. J&J won’t know whether to laugh or cry right now. At least Mr Kransky wasn’t awarded punitive damages, but future cases might challenge that finding again..and again.

Stryker has announced the global commercial launch of the Universal SMARTLock™ Hybrid MMF system. The Universal SMARTLock™ Hybrid MMF system combines elements of both arch bars and MMF screws in what the company says is an effort to bring the standard of care for maxillomandibular fixation techniques into the 21st century.

Positive long-term results for Abbott’s Absorb™ Bioresorbable Vascular Scaffold (BVS) Trial were presented at the 62nd Annual Scientific Session of the American College of Cardiology (ACC) in San Francisco. Three year results from 101 patients show cardiac event rate comparable with metal stents, but improved vasomotion and late lumen gain.