Stryker

OrthoSensor’s VERASENSE™ Intelligent Instrument System is obviously complementing Stryker’s Triathlon® Knee System as the two companies agree to extend their co-marketing arrangement.

Stryker’s Shapematch cutting guide was the subject of a company recall last November. Now the FDA has upgraded the recall to Class I status, indicating the high risk it has placed on use of the device.

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.

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”

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.

Stryker’s preliminary net sales for the fourth quarter of $2.3 billion, and full year 2012 $8.7 billion represent increases of 5.5% and 4.2%, respectively. The company is overhauling international operations in order to fully exploit opportunities in Europe and emerging markets.

Registry data collected from patients undergoing treatment with Wingspan under US Humanitarian device exemption approval has resulted in FDA issuing more limited indications for use. Yet in Europe we seem to be burying our heads in the sand on the device’s shortcomings.

Watch a lovely video of Stryker’s newly released clot-catching Stentriever, called Trevo® ProVue™ because it can be viewed fluoroscopically during the process.

Just a month after taking the hot seat, Kevin Lobo has had something we Brits might call a cabinet reshuffle, bringing in a new man to replace himself in heading up the company’s vital orthopedics business.

sBioMed, which describes itself as an emerging leader in infection control, has announced that Stephen P. MacMillan, former Chairman and CEO of Stryker, has joined as Chief Executive Officer and become an owner of the company.

Stryker’s numbers look pretty solid compared with certain others. However a tough OUS sales environment, coupled with general downward pricing pressure especially in capital goods means the company has had to lower 2012 growth forecasts.

Stryker’s Neuro Division bag is filling nicely with the newly announced acquisition of Surpass Medical, a company with interesting Neuro flow diverter technology in its portfolio.

Stryker Corporation’s Board of Directors announced today that Kevin A. Lobo has been named the Company’s President and Chief Executive Officer, effective immediately. He has also been named to the Company’s Board of Directors. Mr. Lobo joined Stryker in April 2011, and was most recently Group President of Stryker Orthopaedics.

On June 5, 2012, Stryker initiated a Class 1 recall of the Neptune Waste Management System. Now that recall has been expanded to other iterations of the device because it appears they have been marketed without 510(k) clearance which FDA deems necessary in order to establish their safety and efficacy.

Stryker corporation is a big device player with orthopaedics, spine and neuro business to name three. Yet it’s European effort continues to result in falling share and disappointment. Recent management changes haven’t yet borne fruit, but the company is expecting better times ahead. While the medtech business can be a complicated affair, we suggest basic business principles still surely apply.

Stryker Neurovascular’s Trevo® Pro Retriever has gained FDA 510(k) market clearance. The Trevo® Pro Retriever outperformed Stryker’s own Merci® Retriever in a clinical study first published in May, showing improved revascularisation compared with the older generation product.